Palbociclib
Information
- Drug Name
- Palbociclib
- Description
- Entry(CIViC)
- 31
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| liposarcoma |
CDK4 AMPLIFICATION ( ENST00000257904.11 ) CDK4 AMPLIFICATION ( ENST00000257904.11 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 23569312 | Detail |
| renal cell carcinoma |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 23898052 | Detail |
| renal cell carcinoma |
CDKN2B LOSS ( ENST00000276925.7 ) CDKN2B LOSS ( ENST00000276925.7 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 23898052 | Detail |
| skin melanoma |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 24495407 | Detail |
| skin melanoma |
CDK4 p.Arg24Cys (p.R24C) ( ENST00000549606.5, ENST00000312990.10, ENST00000257904.11 ) CDK4 p.Arg24Cys (p.R24C) ( ENST00000257904.11, ENST00000312990.10, ENST00000549606.5 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 1 | 24495407 | Detail |
| ovarian cancer |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 21278246 | Detail |
| estrogen-receptor positive breast cancer |
CDK6 OVEREXPRESSION ( ENST00000265734.8 ) CDK6 OVEREXPRESSION ( ENST00000265734.8 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 27252418 | Detail |
| breast cancer | RB1 LOSS-OF-FUNCTION RB1 LOSS-OF-FUNCTION | D |
Predictive
|
Supports
|
Resistance | Somatic | 3 | 20473330 | Detail |
| mantle cell lymphoma |
CCND1 OVEREXPRESSION ( ENST00000227507.3 ) CCND1 OVEREXPRESSION ( ENST00000227507.3 ) |
B |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 2 | 22383795 | Detail |
| breast cancer |
ESR1 OVEREXPRESSION ( ENST00000206249.8 ) ESR1 OVEREXPRESSION ( ENST00000206249.8 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 25524798 | Detail |
| renal cell carcinoma |
CCND1 AMPLIFICATION ( ENST00000227507.3 ) CCND1 AMPLIFICATION ( ENST00000227507.3 ) |
D |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 2 | 23898052 | Detail |
| Her2-receptor positive breast cancer |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 19874578 | Detail |
| breast cancer |
CCND1 AMPLIFICATION ( ENST00000227507.3 ) CCND1 AMPLIFICATION ( ENST00000227507.3 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 19874578 | Detail |
| mantle cell lymphoma |
CCND1 OVEREXPRESSION ( ENST00000227507.3 ) CCND1 OVEREXPRESSION ( ENST00000227507.3 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 1 | 16690963 | Detail |
| glioblastoma | RB1 LOSS-OF-FUNCTION RB1 LOSS-OF-FUNCTION | D |
Predictive
|
Supports
|
Resistance | Somatic | 3 | 20354191 | Detail |
| ovarian cancer |
CCND1 AMPLIFICATION ( ENST00000227507.3 ) CCND1 AMPLIFICATION ( ENST00000227507.3 ) |
D |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 3 | 21278246 | Detail |
| breast cancer | PIK3CA MUTATION PIK3CA MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 25002028 | Detail |
| estrogen-receptor positive breast cancer |
CCNE1 AMPLIFICATION ( ENST00000262643.8 ) CCNE1 AMPLIFICATION ( ENST00000262643.8 ) |
D |
Predictive
|
Supports
|
Resistance |
N/A
|
3 | 27020857 | Detail |
| estrogen-receptor positive breast cancer |
RB1 p.Met695AsnfsTer26 (p.M695Nfs*26) ( ENST00000267163.6, ENST00000650461.1, ENST00000713856.1, ENST00000713858.1, ENST00000713857.1 ) RB1 p.Met695AsnfsTer26 (p.M695Nfs*26) ( ENST00000267163.6, ENST00000650461.1, ENST00000713856.1, ENST00000713857.1, ENST00000713858.1 ) |
D |
Predictive
|
Supports
|
Resistance | Somatic | 2 | 27020857 | Detail |
| Her2-receptor negative breast cancer |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
C |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26715889 | Detail |
| Ewing sarcoma |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 27286459 | Detail |
| Ewing sarcoma |
CDKN2B LOSS ( ENST00000276925.7 ) CDKN2B LOSS ( ENST00000276925.7 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 27286459 | Detail |
| dermatofibrosarcoma protuberans |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response |
Unknown
|
2 | 25852058 | Detail |
| obsolete T-cell lymphoblastic leukemia/lymphoma |
CCND3 LOSS ( ENST00000372991.9 ) CCND3 LOSS ( ENST00000372991.9 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 23079656 | Detail |
| breast cancer |
ESR1 p.Asp538Gly (p.D538G) ( ENST00000206249.8, ENST00000338799.9, ENST00000406599.5, ENST00000427531.6, ENST00000440973.5, ENST00000443427.5, ENST00000456483.3 ) ESR1 p.Asp538Gly (p.D538G) ( ENST00000206249.8, ENST00000338799.9, ENST00000406599.5, ENST00000427531.6, ENST00000440973.5, ENST00000443427.5, ENST00000456483.3 ) |
B |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 2 | 27556863 | Detail |
| liposarcoma |
CDK4 AMPLIFICATION ( ENST00000257904.11 ) CDK4 AMPLIFICATION ( ENST00000257904.11 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 27124835 | Detail |
| colorectal cancer | KRAS MUTATION KRAS MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 27167191 | Detail |
| sarcoma | CDK4 EXPRESSION CDK4 EXPRESSION | D |
Predictive
|
Supports
|
Sensitivity/Response |
N/A
|
4 | 26528855 | Detail |
| pancreatic cancer | CDKN2A MUTATION CDKN2A MUTATION | B |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 4 | Detail | |
| cholangiocarcinoma | CDKN2A MUTATION CDKN2A MUTATION | B |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 4 | Detail | |
| lung non-small cell carcinoma |
KRAS p.Gly12Val (p.G12V) ( ENST00000688940.1, ENST00000692768.1, ENST00000256078.10, ENST00000311936.8, ENST00000556131.2, ENST00000557334.6, ENST00000685328.1, ENST00000686969.1, ENST00000693229.1 ) KRAS p.Gly12Val (p.G12V) ( ENST00000693229.1, ENST00000256078.10, ENST00000311936.8, ENST00000556131.2, ENST00000557334.6, ENST00000685328.1, ENST00000686969.1, ENST00000688940.1, ENST00000692768.1 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 1 | 20609353 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In a phase 2 clinical trial, NCT01209598, 30 patie... | CDK4 |
CDK4 AMPLIFICATION ( ENST00000257904.11 ) CDK4 AMPLIFICATION ( ENST00000257904.11 ) |
Sensitivity | true | CIViC Evidence | detail |
| Preclinical study of CDK4/6 inhibitor PD-0332991 i... | CDKN2A |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Preclinical study of CDK4/6 inhibitor PD-0332991 i... | CDKN2B |
CDKN2B LOSS ( ENST00000276925.7 ) CDKN2B LOSS ( ENST00000276925.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a cohort of 143 patients with primary invasive ... | CDKN2A |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a cohort of 143 patients with primary invasive ... | CDK4 |
CDK4 p.Arg24Cys (p.R24C) ( ENST00000549606.5, ENST00000312990.10, ENST00000257904.11 ) CDK4 p.Arg24Cys (p.R24C) ( ENST00000257904.11, ENST00000312990.10, ENST00000549606.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Preclinical study of the effects of PD-0332991 on ... | CDKN2A |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Four fulvestrant (estrogen receptor degrader) resi... | CDK6 |
CDK6 OVEREXPRESSION ( ENST00000265734.8 ) CDK6 OVEREXPRESSION ( ENST00000265734.8 ) |
Sensitivity | true | CIViC Evidence | detail |
| In 3 ER positive and 2 ER negative breast cancer c... | RB1 | RB1 LOSS-OF-FUNCTION RB1 LOSS-OF-FUNCTION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| A pharmacodynamic study (NCT00420056) of 17 mantle... | CCND1 |
CCND1 OVEREXPRESSION ( ENST00000227507.3 ) CCND1 OVEREXPRESSION ( ENST00000227507.3 ) |
Sensitivity | false | CIViC Evidence | detail |
| A phase 2 clinical trial evaluated 165 patients wi... | ESR1 |
ESR1 OVEREXPRESSION ( ENST00000206249.8 ) ESR1 OVEREXPRESSION ( ENST00000206249.8 ) |
Sensitivity | true | CIViC Evidence | detail |
| 28 renal cell carcinoma cell lines were tested for... | CCND1 |
CCND1 AMPLIFICATION ( ENST00000227507.3 ) CCND1 AMPLIFICATION ( ENST00000227507.3 ) |
Sensitivity | false | CIViC Evidence | detail |
| In a panel of 47 breast cancer cell lines, HER2 ov... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| A panel of 47 breast cancer cell lines was tested ... | CCND1 |
CCND1 AMPLIFICATION ( ENST00000227507.3 ) CCND1 AMPLIFICATION ( ENST00000227507.3 ) |
Sensitivity | true | CIViC Evidence | detail |
| In Mantle Cell Lymphoma (MCL), t(11:14)-induced ov... | CCND1 |
CCND1 OVEREXPRESSION ( ENST00000227507.3 ) CCND1 OVEREXPRESSION ( ENST00000227507.3 ) |
Sensitivity | true | CIViC Evidence | detail |
| A panel of 21 glioblastoma cell lines harboring va... | RB1 | RB1 LOSS-OF-FUNCTION RB1 LOSS-OF-FUNCTION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| A panel of 40 ovarian cancer cell lines with varie... | CCND1 |
CCND1 AMPLIFICATION ( ENST00000227507.3 ) CCND1 AMPLIFICATION ( ENST00000227507.3 ) |
Sensitivity | false | CIViC Evidence | detail |
| Three PIK3CA mutant breast cancer cell lines were ... | PIK3CA | PIK3CA MUTATION PIK3CA MUTATION | Sensitivity | true | CIViC Evidence | detail |
| Preclinical study in breast cancer cell lines trea... | CCNE1 |
CCNE1 AMPLIFICATION ( ENST00000262643.8 ) CCNE1 AMPLIFICATION ( ENST00000262643.8 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Preclinical study in breast cancer cell lines trea... | RB1 |
RB1 p.Met695AsnfsTer26 (p.M695Nfs*26) ( ENST00000267163.6, ENST00000650461.1, ENST00000713856.1, ENST00000713858.1, ENST00000713857.1 ) RB1 p.Met695AsnfsTer26 (p.M695Nfs*26) ( ENST00000267163.6, ENST00000650461.1, ENST00000713856.1, ENST00000713857.1, ENST00000713858.1 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| A patient with metastatic ER-positive, her2-negati... | CDKN2A |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| A patient-derived xenograft (PDX) from a patient w... | CDKN2A |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| A patient-derived xenograft (PDX) from a patient w... | CDKN2B |
CDKN2B LOSS ( ENST00000276925.7 ) CDKN2B LOSS ( ENST00000276925.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| An imatinib-resistant cell line, DFSP105, was esta... | CDKN2A |
CDKN2A LOSS ( ENST00000579755.2 ) CDKN2A LOSS ( ENST00000579755.2 ) |
Sensitivity | true | CIViC Evidence | detail |
| Treatment of Notch-driven T-cell leukemia in Ccnd3... | CCND3 |
CCND3 LOSS ( ENST00000372991.9 ) CCND3 LOSS ( ENST00000372991.9 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a study of 16 patients with metastatic breast c... | ESR1 |
ESR1 p.Asp538Gly (p.D538G) ( ENST00000206249.8, ENST00000338799.9, ENST00000406599.5, ENST00000427531.6, ENST00000440973.5, ENST00000443427.5, ENST00000456483.3 ) ESR1 p.Asp538Gly (p.D538G) ( ENST00000206249.8, ENST00000338799.9, ENST00000406599.5, ENST00000427531.6, ENST00000440973.5, ENST00000443427.5, ENST00000456483.3 ) |
Sensitivity | false | CIViC Evidence | detail |
| More than 90% of well-differentiated or dedifferen... | CDK4 |
CDK4 AMPLIFICATION ( ENST00000257904.11 ) CDK4 AMPLIFICATION ( ENST00000257904.11 ) |
Sensitivity | true | CIViC Evidence | detail |
| A preclinical study to investigate the efficacy of... | KRAS | KRAS MUTATION KRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| A preclinical study to explore the efficacy of CDK... | CDK4 | CDK4 EXPRESSION CDK4 EXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| In a phase 2 trial, patients with pancreatic cance... | CDKN2A | CDKN2A MUTATION CDKN2A MUTATION | Sensitivity | false | CIViC Evidence | detail |
| In a phase 2 trial, patients with gallbladder canc... | CDKN2A | CDKN2A MUTATION CDKN2A MUTATION | Sensitivity | false | CIViC Evidence | detail |
| In vivo studies confirmed the activity of PD033299... | KRAS |
KRAS p.Gly12Val (p.G12V) ( ENST00000688940.1, ENST00000692768.1, ENST00000256078.10, ENST00000311936.8, ENST00000556131.2, ENST00000557334.6, ENST00000685328.1, ENST00000686969.1, ENST00000693229.1 ) KRAS p.Gly12Val (p.G12V) ( ENST00000693229.1, ENST00000256078.10, ENST00000311936.8, ENST00000556131.2, ENST00000557334.6, ENST00000685328.1, ENST00000686969.1, ENST00000688940.1, ENST00000692768.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT02905318 | Active, not recruiting | Phase 2 | Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer | July 4, 2017 | December 30, 2024 |
| NCT03981614 | Active, not recruiting | Phase 2 | Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer | October 29, 2019 | April 3, 2024 |
| NCT03959891 | Active, not recruiting | Phase 1 | AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC) | May 30, 2019 | December 2024 |
| NCT03900884 | Active, not recruiting | Phase 1 | Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer | September 25, 2019 | December 2025 |
| NCT03870919 | Active, not recruiting | N/A | Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients | October 23, 2019 | October 23, 2027 |
| NCT02942355 | Active, not recruiting | Phase 2 | Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer | December 7, 2016 | June 30, 2026 |
| NCT02947685 | Active, not recruiting | Phase 3 | Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer | June 21, 2017 | July 31, 2026 |
| NCT03006172 | Active, not recruiting | Phase 1 | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer | December 13, 2016 | November 30, 2024 |
| NCT02297438 | Active, not recruiting | Phase 3 | A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4] | March 23, 2015 | December 31, 2024 |
| NCT03024489 | Active, not recruiting | Phase 1/Phase 2 | Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma | July 19, 2017 | December 31, 2024 |
| NCT03854903 | Active, not recruiting | Phase 1 | WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor | April 1, 2019 | November 1, 2025 |
| NCT03065387 | Active, not recruiting | Phase 1 | Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation | October 31, 2017 | October 1, 2025 |
| NCT02592083 | Active, not recruiting | Phase 2 | Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors | October 2015 | February 2029 |
| NCT03088059 | Active, not recruiting | Phase 2 | Biomarker-based Study in R/M SCCHN | November 16, 2017 | December 2025 |
| NCT04931342 | Active, not recruiting | Phase 2 | A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors | October 7, 2021 | December 31, 2028 |
| NCT03792256 | Active, not recruiting | Phase 1 | Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) | April 11, 2019 | June 30, 2025 |
| NCT03784014 | Active, not recruiting | Phase 3 | Molecular Profiling of Advanced Soft-tissue Sarcomas | October 19, 2019 | October 2025 |
| NCT03147287 | Active, not recruiting | Phase 2 | Palbociclib After CDK and Endocrine Therapy (PACE) | September 5, 2017 | December 31, 2024 |
| NCT03709680 | Active, not recruiting | Phase 1/Phase 2 | Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors | May 24, 2019 | February 25, 2025 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT03170206 | Active, not recruiting | Phase 1 | Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer | May 31, 2017 | June 30, 2025 |
| NCT05759949 | Active, not recruiting | Phase 1 | First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors | March 29, 2023 | July 25, 2024 |
| NCT02605486 | Active, not recruiting | Phase 1/Phase 2 | Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) | November 11, 2015 | November 2024 |
| NCT03685331 | Active, not recruiting | Phase 1 | HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer | October 15, 2020 | April 2024 |
| NCT03633331 | Active, not recruiting | Phase 2 | Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer | August 15, 2018 | August 2024 |
| NCT04711252 | Active, not recruiting | Phase 3 | A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease | January 28, 2021 | February 1, 2029 |
| NCT03238196 | Active, not recruiting | Phase 1 | Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer | August 18, 2017 | September 25, 2024 |
| NCT03609047 | Active, not recruiting | Phase 2 | Adjuvant Palbociclib in Elderly Patients With Breast Cancer | June 14, 2019 | September 30, 2032 |
| NCT03573648 | Active, not recruiting | Phase 2 | Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer | November 13, 2018 | December 31, 2025 |
| NCT03284957 | Active, not recruiting | Phase 1/Phase 2 | Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer | September 20, 2017 | December 29, 2027 |
| NCT02664935 | Active, not recruiting | Phase 2 | National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer | May 2015 | September 2024 |
| NCT03526250 | Active, not recruiting | Phase 2 | Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) | August 13, 2018 | September 22, 2024 |
| NCT03304080 | Active, not recruiting | Phase 1/Phase 2 | Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast | December 20, 2017 | December 2024 |
| NCT03498378 | Active, not recruiting | Phase 1 | Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | June 6, 2018 | December 2024 |
| NCT03332797 | Active, not recruiting | Phase 1 | A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer | November 27, 2017 | June 30, 2025 |
| NCT03478514 | Active, not recruiting | Phase 2 | Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma | September 11, 2018 | December 2025 |
| NCT03446157 | Active, not recruiting | Phase 2 | Palbociclib and Cetuximab in Metastatic Colorectal Cancer | March 13, 2018 | January 26, 2026 |
| NCT03389477 | Active, not recruiting | Phase 2 | Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma | April 27, 2018 | April 6, 2027 |
| NCT03423199 | Active, not recruiting | Phase 3 | PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY | February 9, 2018 | September 2025 |
| NCT02668666 | Active, not recruiting | Phase 2 | Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer | June 30, 2016 | November 2023 |
| NCT05266105 | Active, not recruiting | Phase 1 | A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients | December 10, 2021 | July 2025 |
| NCT05039177 | Active, not recruiting | Phase 1/Phase 2 | A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies | September 20, 2021 | December 2024 |
| NCT04591431 | Active, not recruiting | Phase 2 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | October 7, 2020 | June 2025 |
| NCT02738866 | Active, not recruiting | Phase 2 | Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor | October 25, 2016 | December 2024 |
| NCT04546009 | Active, not recruiting | Phase 3 | A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) | October 9, 2020 | March 18, 2027 |
| NCT02764541 | Active, not recruiting | Phase 2 | Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS) | May 24, 2016 | April 2031 |
| NCT04439201 | Active, not recruiting | Phase 2 | Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B) | May 31, 2016 | December 31, 2025 |
| NCT04438824 | Active, not recruiting | Phase 2 | Palbociclib and INCMGA00012 in People With Advanced Liposarcoma | June 17, 2020 | June 2025 |
| NCT05178888 | Active, not recruiting | Phase 1 | Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16) | February 1, 2022 | December 31, 2024 |
| NCT02513394 | Active, not recruiting | Phase 3 | PALbociclib CoLlaborative Adjuvant Study | August 2015 | September 2025 |
| NCT06390839 | Active, not recruiting | Phase 2 | Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C) | March 12, 2017 | March 24, 2025 |
| NCT02159755 | Active, not recruiting | Phase 1 | Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma | May 20, 2014 | January 20, 2025 |
| NCT05909397 | Active, not recruiting | Phase 3 | A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer | August 9, 2023 | July 26, 2030 |
| NCT04224272 | Active, not recruiting | Phase 2 | A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer | June 10, 2020 | October 26, 2025 |
| NCT04191499 | Active, not recruiting | Phase 2/Phase 3 | A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer | January 29, 2020 | September 30, 2030 |
| NCT02897375 | Completed | Phase 1 | Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors | October 24, 2016 | October 15, 2021 |
| NCT01942135 | Completed | Phase 3 | Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) | September 26, 2013 | September 28, 2022 |
| NCT01953731 | Completed | Phase 1 | A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991) | October 2013 | January 2014 |
| NCT02022982 | Completed | Phase 1 | PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors | January 2014 | June 30, 2021 |
| NCT02028507 | Completed | Phase 3 | Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors | March 13, 2014 | January 11, 2021 |
| NCT02040857 | Completed | Phase 2 | Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer | January 2014 | May 2020 |
| NCT02059330 | Completed | Phase 1 | A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects | March 2014 | June 2014 |
| NCT02065063 | Completed | Phase 1 | A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors | April 22, 2014 | June 23, 2016 |
| NCT02085538 | Completed | Phase 1 | Study Of Palbociclib (PD-0332991) In Renal Impairment | May 2014 | May 2016 |
| NCT02154490 | Completed | Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer | July 8, 2014 | April 15, 2022 | |
| NCT02296801 | Completed | Phase 2 | A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer | January 2015 | March 2019 |
| NCT02384239 | Completed | Phase 2 | A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer | October 19, 2015 | January 31, 2021 |
| NCT02400567 | Completed | Phase 2 | Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women | January 2015 | September 2020 |
| NCT02448420 | Completed | Phase 2 | Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer | July 2015 | November 30, 2023 |
| NCT02448771 | Completed | Phase 1/Phase 2 | A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer | July 9, 2015 | March 3, 2021 |
| NCT02491983 | Completed | Phase 2 | Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer | August 2015 | January 2020 |
| NCT02499120 | Completed | Phase 2 | Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer | September 10, 2015 | September 7, 2022 |
| NCT02501902 | Completed | Phase 1 | Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC | November 23, 2015 | December 27, 2018 |
| NCT02530320 | Completed | Phase 2 | Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved | October 25, 2015 | March 2020 |
| NCT02530424 | Completed | Phase 2 | "Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment " | May 2015 | November 2019 |
| NCT02536742 | Completed | Phase 2 | Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer | August 30, 2016 | December 22, 2022 |
| NCT02549430 | Completed | Phase 2 | To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy | October 2012 | February 9, 2017 |
| NCT02599714 | Completed | Phase 1 | Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer | December 7, 2015 | November 23, 2023 |
| NCT02600923 | Completed | Phase 3 | Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate | April 15, 2016 | May 28, 2019 |
| NCT02679755 | Completed | Phase 4 | Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer | March 9, 2016 | July 25, 2019 |
| NCT02684032 | Completed | Phase 1 | A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer | June 14, 2016 | January 19, 2022 |
| NCT02785939 | Completed | Phase 2/Phase 3 | Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer | September 2014 | June 2019 |
| NCT02806050 | Completed | Phase 2 | Palbociclib and FES PET | September 16, 2016 | September 28, 2022 |
| NCT02806648 | Completed | Phase 2 | A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET) | May 2015 | January 2018 |
| NCT02871791 | Completed | Phase 1/Phase 2 | Palbociclib With Everolimus + Exemestane In BC | August 24, 2016 | September 2021 |
| NCT02894398 | Completed | Phase 2 | Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant | September 6, 2016 | February 15, 2023 |
| NCT03007979 | Completed | Phase 2 | Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer | June 15, 2017 | March 31, 2023 |
| NCT03065621 | Completed | Phase 2 | Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA) | July 5, 2017 | February 1, 2023 |
| NCT03110744 | Completed | Phase 2 | CDK4/6 Inhibition in Locally Advanced/Metastatic Chordoma | December 15, 2017 | December 22, 2022 |
| NCT03158389 | Completed | Phase 1/Phase 2 | NCT Neuro Master Match - N²M² (NOA-20) | May 7, 2018 | February 22, 2023 |
| NCT03184090 | Completed | Phase 2 | Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC | June 28, 2017 | October 27, 2020 |
| NCT03194373 | Completed | Phase 2 | Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | October 12, 2017 | March 17, 2020 |
| NCT03220191 | Completed | Phase 1 | Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib | July 21, 2017 | September 26, 2017 |
| NCT03285568 | Completed | Patterns of Prescribing and Monitoring of Palbociclib | February 3, 2015 | December 30, 2016 | |
| NCT03455270 | Completed | Phase 1 | G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer | May 9, 2018 | September 29, 2022 |
| NCT03471663 | Completed | Phase 1 | A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer | March 18, 2018 | October 18, 2023 |
| NCT03472573 | Completed | Phase 1 | Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia | May 9, 2018 | June 9, 2022 |
| NCT03530696 | Completed | Phase 2 | T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer | December 6, 2018 | December 22, 2022 |
| NCT03560531 | Completed | Phase 1/Phase 2 | A Study of ZN-c5 in Subjects With Breast Cancer | December 8, 2018 | December 22, 2022 |
| NCT03628066 | Completed | Phase 2 | Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer | October 22, 2018 | January 30, 2021 |
| NCT03644186 | Completed | Phase 2 | To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) | April 16, 2019 | April 14, 2023 |
| NCT03691493 | Completed | Phase 2 | Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis | February 8, 2019 | October 13, 2022 |
| NCT03774472 | Completed | Phase 1/Phase 2 | Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer | August 20, 2018 | April 17, 2024 |
| NCT03809988 | Completed | Phase 2 | PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) | April 5, 2019 | November 30, 2022 |
| NCT03921866 | Completed | UK Ibrance Patient Program (IPP) Study | March 1, 2019 | March 4, 2021 | |
| NCT03969121 | Completed | Phase 3 | Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer | July 16, 2019 | December 23, 2021 |
| NCT04075604 | Completed | Phase 2 | A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer | October 18, 2019 | July 27, 2021 |
| NCT04109261 | Completed | Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe | September 18, 2018 | September 1, 2019 | |
| NCT04129151 | Completed | Phase 2 | Palbociclib + Ganitumab In Ewing Sarcoma | December 5, 2019 | December 15, 2022 |
| NCT04130152 | Completed | Early Phase 1 | Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy | November 21, 2019 | February 24, 2022 |
| NCT04256941 | Completed | Phase 2 | Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study | May 31, 2019 | September 22, 2023 |
| NCT04436744 | Completed | Phase 2 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer) | September 4, 2020 | November 24, 2021 |
| NCT04524728 | Completed | Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy | December 2016 | June 2020 | |
| NCT04671615 | Completed | A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel. | December 6, 2020 | January 1, 2023 | |
| NCT04992156 | Completed | Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET | March 15, 2017 | April 15, 2022 | |
| NCT05141240 | Completed | A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors | April 15, 2020 | June 15, 2020 | |
| NCT05153135 | Completed | Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors | May 8, 2020 | July 31, 2020 | |
| NCT05384119 | Completed | Phase 1/Phase 2 | Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer | January 9, 2023 | April 25, 2024 |
| NCT06003114 | Completed | A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs | October 6, 2023 | February 22, 2024 | |
| NCT06086340 | Completed | Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself. | September 29, 2023 | January 24, 2024 | |
| NCT02142868 | No longer available | Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate | |||
| NCT06338644 | Not yet recruiting | Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients. | July 1, 2024 | September 1, 2026 | |
| NCT05949424 | Not yet recruiting | Phase 4 | OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults | May 2024 | March 2025 |
| NCT06380751 | Not yet recruiting | Phase 3 | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer | April 18, 2024 | July 18, 2030 |
| NCT06377852 | Not yet recruiting | Phase 3 | The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study | October 28, 2024 | September 1, 2028 |
| NCT05067530 | Not yet recruiting | Phase 2 | Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study | January 1, 2022 | December 6, 2026 |
| NCT06076772 | Not yet recruiting | Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients | November 2023 | December 2026 | |
| NCT04605562 | Not yet recruiting | Phase 2 | Umbrella Biomarker-Guided Therapy in NPC | June 2022 | December 2026 |
| NCT03065062 | Recruiting | Phase 1 | Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors | February 28, 2017 | January 2026 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT05867251 | Recruiting | Phase 1/Phase 2 | Study of AVZO-021 in Patients With Advanced Solid Tumors | August 30, 2023 | January 31, 2030 |
| NCT05935748 | Recruiting | Phase 2 | Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc) | July 28, 2023 | September 2026 |
| NCT06065592 | Recruiting | Phase 1 | Exploring Cancer-Associated Thromboembolism Prognosis Biomarkers and Polymorphisms | February 1, 2019 | December 2024 |
| NCT04185883 | Recruiting | Phase 1 | Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) | December 17, 2019 | December 31, 2027 |
| NCT04247633 | Recruiting | Phase 2 | High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx) | February 11, 2020 | February 2025 |
| NCT06065748 | Recruiting | Phase 3 | A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) | December 11, 2023 | December 30, 2028 |
| NCT04360941 | Recruiting | Phase 1 | PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer | August 11, 2020 | December 31, 2025 |
| NCT02778685 | Recruiting | Phase 2 | Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer | September 30, 2016 | December 30, 2024 |
| NCT02760030 | Recruiting | Phase 2 | Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery | February 16, 2017 | December 31, 2024 |
| NCT04567420 | Recruiting | Phase 2 | DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer | February 9, 2021 | December 15, 2026 |
| NCT02693535 | Recruiting | Phase 2 | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer | March 14, 2016 | December 31, 2025 |
| NCT04606446 | Recruiting | Phase 1 | Study of PF-07248144 in Advanced or Metastatic Solid Tumors | November 16, 2020 | November 8, 2026 |
| NCT04654208 | Recruiting | Swedish Ibrance Registries Insights (SIRI) | December 15, 2020 | August 31, 2024 | |
| NCT06113809 | Recruiting | Phase 1 | Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS) | February 1, 2024 | July 2028 |
| NCT04720768 | Recruiting | Phase 1/Phase 2 | Encorafenib, Binimetinib and Palbociclib in BRAF-mutant Metastatic Melanoma CELEBRATE | June 4, 2020 | December 4, 2024 |
| NCT04802759 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer | June 20, 2021 | October 31, 2026 |
| NCT04841148 | Recruiting | Phase 2 | Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer | June 1, 2021 | May 2028 |
| NCT04862663 | Recruiting | Phase 3 | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) | May 10, 2021 | August 14, 2029 |
| NCT04946864 | Recruiting | Phase 1/Phase 2 | A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer | August 13, 2021 | October 1, 2024 |
| NCT04964934 | Recruiting | Phase 3 | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) | June 30, 2021 | November 26, 2027 |
| NCT04966481 | Recruiting | Phase 3 | Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor | April 6, 2022 | February 28, 2027 |
| NCT06126276 | Recruiting | Phase 2 | Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial) | May 7, 2024 | April 30, 2025 |
| NCT04996160 | Recruiting | Phase 1 | Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2) | July 9, 2021 | December 2025 |
| NCT05076695 | Recruiting | Phase 2 | Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer | October 15, 2021 | October 15, 2024 |
| NCT05135104 | Recruiting | Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period | December 15, 2021 | May 25, 2024 | |
| NCT06188520 | Recruiting | Phase 1/Phase 2 | A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors | December 5, 2023 | June 18, 2025 |
| NCT05226871 | Recruiting | Phase 2 | Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies | July 7, 2022 | April 19, 2026 |
| NCT05293964 | Recruiting | Phase 1 | Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer | May 18, 2022 | September 8, 2025 |
| NCT05399329 | Recruiting | Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan | April 20, 2022 | May 31, 2025 | |
| NCT05432518 | Recruiting | Early Phase 1 | Pilot Trial for Treatment of Recurrent Glioblastoma | June 27, 2023 | December 1, 2027 |
| NCT05468697 | Recruiting | Phase 1/Phase 2 | A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024) | August 10, 2022 | March 16, 2027 |
| NCT03454035 | Recruiting | Phase 1 | Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors | January 30, 2018 | April 24, 2026 |
| NCT05501886 | Recruiting | Phase 3 | Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) | September 30, 2022 | September 30, 2026 |
| NCT05554367 | Recruiting | Phase 2 | Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial | December 13, 2023 | August 26, 2026 |
| NCT05563220 | Recruiting | Phase 1/Phase 2 | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer | January 24, 2023 | August 31, 2026 |
| NCT03297606 | Recruiting | Phase 2 | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) | March 23, 2018 | January 31, 2027 |
| NCT05564377 | Recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | April 7, 2023 | July 1, 2030 |
| NCT05627232 | Recruiting | Phase 1 | Palbociclib or Tazemetostat in Combination With CPX-351 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia | August 28, 2023 | January 2026 |
| NCT03242382 | Recruiting | Phase 2 | Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression. | March 31, 2017 | September 30, 2024 |
| NCT05694871 | Recruiting | Phase 2 | Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma | May 30, 2023 | May 31, 2027 |
| NCT05725200 | Recruiting | Phase 2 | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer | September 27, 2022 | December 31, 2040 |
| NCT03155620 | Recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | July 31, 2017 | September 30, 2027 |
| NCT05766410 | Recruiting | Phase 2 | A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC | September 16, 2022 | September 30, 2026 |
| NCT03132454 | Recruiting | Phase 1 | Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia | July 25, 2017 | December 31, 2024 |
| NCT05865132 | Recruiting | Phase 2 | Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction | April 6, 2023 | April 2026 |
| NCT02896335 | Recruiting | Phase 2 | Palbociclib In Progressive Brain Metastases | February 14, 2017 | September 2025 |
| NCT01823835 | Terminated | Phase 1/Phase 2 | A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer | December 29, 2014 | March 13, 2020 |
| NCT03128619 | Terminated | Phase 1 | Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer | August 2, 2017 | March 31, 2022 |
| NCT03220178 | Terminated | Phase 4 | Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy | July 24, 2017 | December 7, 2021 |
| NCT04060862 | Terminated | Phase 3 | A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer | November 15, 2019 | August 29, 2023 |
| NCT02774681 | Terminated | Phase 2 | Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis | August 31, 2016 | February 16, 2020 |
| NCT04478266 | Terminated | Phase 3 | Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer | October 14, 2020 | May 26, 2023 |
| NCT02030483 | Terminated | Phase 1 | Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma | February 2014 | July 2016 |
| NCT02349633 | Terminated | Phase 1/Phase 2 | Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M) | May 14, 2015 | May 28, 2020 |
| NCT03322215 | Terminated | Phase 2 | HR+/HER2- Advanced Breast Cancer and Endocrine Resistance | October 24, 2017 | October 31, 2023 |
| NCT02907918 | Terminated | Phase 2 | Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer | June 30, 2017 | September 23, 2020 |
| NCT02334527 | Terminated | Phase 2 | Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy | March 17, 2015 | September 28, 2017 |
| NCT04801966 | Terminated | N/A | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study | September 23, 2021 | December 30, 2022 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT03535506 | Terminated | Phase 2 | Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery | October 8, 2018 | December 6, 2023 |
| NCT03386929 | Terminated | Phase 1/Phase 2 | Survival Prolongation by Rationale Innovative Genomics | November 29, 2017 | December 29, 2022 |
| NCT03709082 | Terminated | Phase 1/Phase 2 | Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer | October 15, 2018 | February 3, 2021 |
| NCT02917005 | Unknown status | Phase 2 | PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer | May 7, 2019 | December 2023 |
| NCT04856371 | Unknown status | Phase 1 | Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer | April 2021 | December 2022 |
| NCT04858997 | Unknown status | Phase 2 | Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients | April 22, 2021 | June 30, 2023 |
| NCT04669587 | Unknown status | Phase 1/Phase 2 | ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study) | July 26, 2021 | January 31, 2024 |
| NCT03454919 | Unknown status | Phase 2 | Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations | March 30, 2018 | June 30, 2020 |
| NCT04526028 | Unknown status | Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China | September 13, 2019 | May 31, 2023 | |
| NCT03756090 | Unknown status | N/A | The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer | December 1, 2018 | November 30, 2020 |
| NCT02626507 | Unknown status | Phase 1 | Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer | January 2016 | March 15, 2022 |
| NCT02592746 | Unknown status | Phase 2 | A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC | June 2016 | June 2021 |
| NCT03239015 | Unknown status | Phase 2 | Efficacy and Safety of Precision Therapy in Refractory Tumor | January 1, 2017 | December 31, 2023 |
| NCT02913430 | Unknown status | Early Phase 1 | Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib | April 24, 2018 | October 28, 2021 |
| NCT02499146 | Unknown status | Phase 1 | Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer | September 11, 2015 | January 30, 2023 |
| NCT03219554 | Unknown status | Phase 2 | A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor | August 2017 | December 2020 |
| NCT04289974 | Unknown status | Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer | February 14, 2019 | April 2022 | |
| NCT04318223 | Unknown status | Phase 2 | Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy | July 16, 2019 | July 31, 2023 |
| NCT02310243 | Unknown status | Phase 1/Phase 2 | Study of Palbociclib in MLL-rearranged Acute Leukemias | July 2015 | July 2019 |
| NCT04852081 | Unknown status | Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study. | January 1, 2021 | December 1, 2021 | |
| NCT04870034 | Withdrawn | Early Phase 1 | Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer | January 15, 2024 | September 30, 2026 |
| NCT04872608 | Withdrawn | Phase 1 | A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer | September 9, 2021 | April 25, 2023 |
| NCT05238831 | Withdrawn | Early Phase 1 | SMMART Adaptive Clinical Treatment (ACT) Trial | January 30, 2023 | May 31, 2026 |
| NCT05371275 | Withdrawn | Phase 2 | Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation | April 21, 2022 | December 2022 |
| NCT03377101 | Withdrawn | Phase 2 | Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer | August 7, 2018 | August 7, 2018 |
| NCT04498520 | Withdrawn | Phase 1 | Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer | March 31, 2021 | June 30, 2025 |
| NCT05176288 | Withdrawn | Phase 2 | Avelumab, Palbociclib and Axitinib in Advanced RCC | May 31, 2024 | August 31, 2027 |
| NCT04585724 | Withdrawn | Phase 1 | Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases | June 12, 2020 | September 13, 2021 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Ibrance
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2015
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- Phase III
- Target (Drug list of Screening Committee of Anticancer Drugs)
- CDK4
- Target (Drug list of Screening Committee of Anticancer Drugs)
- 6
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- 乳がん