13 active not recruiting. 13 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Active not recruiting 13 |
| Phase 2 | 1 | Active not recruiting 1 |
Follow palbociclib: new trials by email Literature Review of palbociclib trials Research Report on palbociclib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease PF-07220060, letrozole, abemaciclib - Breast Cancer | Phase 3 | Active not recruiting | Pfizer | 1035 | 2025-01-06 | 2026-10-16 |
| 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) Giredestrant, Fulvestrant, Abemaciclib - Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer | Phase 3 | Active not recruiting | Hoffmann-La Roche | 1050 | 2023-12-11 | 2026-09-14 |
| Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer Vepdegestrant (ARV-471/PF-07850327), Palbociclib, Letrozole - Breast Cancer | Phase 3 | Active not recruiting | Pfizer | 59 | 2023-08-09 | 2026-02-10 |
| 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) Gedatolisib, Palbociclib, Fulvestrant - Breast Cancer | Phase 3 | Active not recruiting | Celcuity Inc | 701 | 2022-12-08 | 2026-02-10 |
| Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) AZD9833, AZD9833 Placebo, Anastrozole - ER-Positive HER2-Negative Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 315 | 2021-06-30 | 2026-09-23 |
| Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) Capivasertib, Fulvestrant, Palbociclib - Locally Advanced (Inoperable) or Metastatic Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 893 | 2021-05-10 | 2026-08-17 |
| 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 AZD9833, Anastrozole, Anastrozole placebo - ER-Positive HER2-Negative Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 1371 | 2021-01-28 | 2026-09-28 |
| 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) Giredestrant, Giredestrant-matched Placebo, Letrozole - Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer | Phase 3 | Active not recruiting | Hoffmann-La Roche | 992 | 2020-10-09 | 2026-08-17 |
| A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer Inavolisib, Placebo, Palbociclib - Breast Cancer | Phase 2 / Phase 3 | Active not recruiting | Hoffmann-La Roche | 325 | 2020-01-29 | 2026-09-11 |
| Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer Palbociclib 125mg, Standard endocrine therapy - Breast Cancer Recurrent | Phase 3 | Active not recruiting | ETOP IBCSG Partners Foundation | 405 | 2019-08-27 | 2026-09-03 |
| Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant - Breast Neoplasm Female | Phase 3 | Active not recruiting | Borstkanker Onderzoek Groep | 1050 | 2017-11-09 | 2026-05-20 |
| Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer palbociclib, trastuzumab, pertuzumab - HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer | Phase 3 | Active not recruiting | Alliance Foundation Trials, LLC. | 518 | 2017-06-21 | 2026-10-22 |
| PALbociclib CoLlaborative Adjuvant Study Palbociclib, Standard Adjuvant Endocrine Therapy - Breast Cancer | Phase 3 | Active not recruiting | Alliance Foundation Trials, LLC. | 5796 | 2015-08-01 | 2026-06-15 |
Breast Neoplasms (9) · Neoplasm Metastasis (3) · Breast Diseases (2) · Neoplasms (2) · Neoplasms by Site (2) · Recurrence (1) · Skin Diseases (1) · Unilateral Breast Neoplasms (1)
AstraZeneca (3) · Hoffmann-La Roche (3) · Alliance Foundation Trials, LLC. (2) · Pfizer (2) · Borstkanker Onderzoek Groep (1) · Celcuity Inc (1) · ETOP IBCSG Partners Foundation (1)
Italy (12) · Spain (12) · United States (11) · Australia (10) · France (10) · Germany (10) · Hungary (10) · Belgium (9) · Canada (9) · Poland (9) · South Korea (9) · Taiwan (9) · United Kingdom (8) · Austria (7) · Brazil (7)
A E van Leeuwen-Stok, PhD (1) · A. Jager, MD, PhD (1) · Angela DeMichele, MD (1) · Elisabetta Munzone, MD (1) · Erica Mayer, MD (1) · Evanthia Galanis, MD (1) · Michael Gnant, MD (1) · Nadene Zack (1)
PMID 12954578, PMID 25524798, PMID 30032196, PMID 30458732, PMID 33369581, PMID 33460574, PMID 34874182, PMID 34995105, PMID 37070653, PMID 37556775, PMID 39476340, PMID 39849600, PMID 40140172, PMID 40454637, PMID 40454641, PMID 40908356, PMID 41207182, PMID 41270788, PMID 41604639, PMID 41712229, PMID 41802242, PMID 42442380, PMID 42496653
2023 (3), 2014 (1), 2017 (1), 2018 (1), 2019 (1)