13 active not recruiting, 12 completed, 7 recruiting, 3 unknown. 39 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 39 | Active not recruiting 13, Completed 12, Recruiting 7, Unknown 3, Not yet recruiting 2, Terminated 2 |
| Phase 2 | 3 | Completed 2, 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 |
|---|---|---|---|---|---|---|
| A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer HRS-6209 + Letrozole, Dalpciclib/Palbociclib + Letrozole/Anastrozole - Breast Cancer | Phase 3 | Not yet recruiting | Jiangsu HengRui Medicine Co., Ltd. | 1050 | 2026-11-20 | 2026-10-26 |
| T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd Trastuzumab deruxtecan, Trastuzumab, Pertuzumab - Advanced Breast Cancer, Metastatic Breast Cancer | Phase 3 | Recruiting | Daiichi Sankyo | 200 | 2026-09-18 | 2026-10-16 |
| BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease BGB-43395, Letrozole, Abemaciclib - HR+/HER2- Breast Cancer | Phase 3 | Recruiting | BeOne Medicines | 1056 | 2026-05-22 | 2026-10-26 |
| A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) LY4064809, Placebo, Ribociclib - Breast Neoplasms, Neoplasm Metastasis | Phase 3 | Recruiting | Eli Lilly and Company | 800 | 2025-12-22 | 2026-10-08 |
| Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole - Breast Cancer | Phase 3 | Recruiting | Celcuity Inc | 1180 | 2025-07-24 | 2026-10-09 |
| Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid - Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer | Phase 3 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 474 | 2025-07-01 | 2025-07-11 |
| 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 |
| The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study Palbociclib 125mg, Ribociclib 600mg, Ribociclib - Metastatic Breast Cancer | Phase 3 | Recruiting | American Society of Clinical Oncology | 500 | 2024-10-29 | 2026-10-06 |
| Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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 Saruparib (AZD5305), Camizestrant, Abemaciclib - Advanced Breast Cancer | Phase 3 | Recruiting | AstraZeneca | 788 | 2024-08-01 | 2026-09-02 |
| 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 |
| 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 Palbociclib, Cetuximab - HPV-unrelated Head and Neck Squamous Cell Carcinoma | Phase 3 | Recruiting | Washington University School of Medicine | 81 | 2022-04-06 | 2026-09-22 |
| Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant, Paclitaxel +/- Tislelizumab - Metastatic Breast Cancer | Phase 3 | Terminated | SOLTI Breast Cancer Research Group | 61 | 2022-03-28 | 2026-06-25 |
| 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 |
| Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer Trastuzumab, Pertuzumab, Nab paclitaxel - HER2+ Breast Cancer | Phase 3 | Unknown | First Affiliated Hospital Xi'an Jiaotong University | 120 | 2021-01-01 | 2022-06-23 |
| Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer Amcenestrant-matching placebo, SAR439859, Palbociclib - Breast Cancer | Phase 3 | Terminated | Sanofi | 1068 | 2020-10-14 | 2025-09-11 |
| 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 |
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Breast Neoplasms (27) · Neoplasm Metastasis (9) · Breast Diseases (2) · Neoplasms (2) · Neoplasms by Site (2) · Recurrence (1) · Sarcoma (1) · Skin Diseases (1) · Unilateral Breast Neoplasms (1)
Pfizer (6) · AstraZeneca (4) · Hoffmann-La Roche (3) · Alliance Foundation Trials, LLC. (2) · Celcuity Inc (2) · American Society of Clinical Oncology (1) · BeOne Medicines (1) · Borstkanker Onderzoek Groep (1) · Daiichi Sankyo (1) · ETOP IBCSG Partners Foundation (1) · Eli Lilly and Company (1) · First Affiliated Hospital Xi'an Jiaotong University (1) · GBG Forschungs GmbH (1) · Georgetown University (1) · Institut National de la Santé Et de la Recherche Médicale, France (1)
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A E van Leeuwen-Stok, PhD (1) · A. Jager, MD, PhD (1) · Aleix Prat, MD (1) · Angela DeMichele, MD (1) · Antoine Italiano (1) · Caigang Liu (1) · Claudine Isaacs, MD (1) · Dan G Stover, MD (1) · Douglas Adkins, M.D. (1)
PMID 30032196, PMID 29342248, PMID 29522361, PMID 30053671, PMID 31127500, PMID 32164785, PMID 32783178, PMID 33486783, PMID 33955129, PMID 35974168, PMID 36463643, PMID 38861871, PMID 12954578, PMID 25524798, PMID 26030518, PMID 26947331, PMID 27029704, PMID 27269946, PMID 27368881, PMID 27959613, PMID 28652278, PMID 29360932, PMID 30308388, PMID 30345905, PMID 30392115, PMID 30458732, PMID 30515674, PMID 30632023, PMID 30807234, PMID 31125276, PMID 31217344, PMID 31836434, PMID 32315295, PMID 32713836, PMID 33211314, PMID 33369581, PMID 33385521, PMID 33460574, PMID 33793299, PMID 34037282, PMID 34157782, PMID 34388698, PMID 34425406, PMID 34740331, PMID 34874182, PMID 34995105, PMID 35241469, PMID 35309087, PMID 35429901, PMID 36155117
2023 (3), 2017 (2), 2025 (2), 2014 (1), 2016 (1), 2018 (1), 2019 (1), U10CA180888 (1)