8 completed, 6 recruiting, 2 active not recruiting, 2 withdrawn. 10 Phase 2, 5 Phase 1, 4 Phase 3, 1 Phase 4.
Follow Palbociclib 125mg: new trials by email Literature Review of Palbociclib 125mg trials Research Report on Palbociclib 125mg
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 Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet - Metastatic Breast Cancer, Breast Cancer Stage I | Phase 1 / Phase 2 | Recruiting | Forward Pharmaceuticals Co., Ltd. | 196 | 2025-06-01 | 2026-01-07 |
| 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 |
| Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg Palbociclib 125mg - Bioequivalence | Phase 4 | Completed | Megalabs | 24 | 2024-02-06 | 2024-08-19 |
| Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA SNP, Palbociclib 125mg, Bevacizumab - Cancer, Solid Tumor | Phase 1 | Recruiting | Lebanese University | 50 | 2023-02-15 | 2024-03-12 |
| Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study) Fulvestrant Injectable Product, Letrozole 2.5mg, Palbociclib 125mg - Metastatic Breast Cancer, Advanced Breast Cancer | Completed | MedSIR | 419 | 2022-07-18 | 2024-12-13 | |
| Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy Palbociclib 125mg - Breast Cancer | Phase 2 | Active not recruiting | University of Nebraska | 51 | 2022-03-02 | 2026-10-09 |
| First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer RLY-2608, Fulvestrant, Palbociclib 125mg - PIK3CA Mutation, Solid Tumor, Adult | Phase 1 | Recruiting | Relay Therapeutics, Inc. | 930 | 2021-12-08 | 2025-09-22 |
| Combined Immunotherapies in Metastatic ER+ Breast Cancer Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg - Breast Cancer | Phase 2 | Recruiting | Weill Medical College of Cornell University | 102 | 2020-11-12 | 2025-12-15 |
| PLATFORM Study of Precision Medicine for Rare Tumors Almonertinib 110 MG, Dacomitinib 45 MG, Alectinib 150 MG - Rare Tumor | Phase 2 | Recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 770 | 2020-08-15 | 2025-02-11 |
| Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer Palbociclib 125mg, Letrozole 2.5mg - Ovarian Cancer | Phase 2 | Completed | Latin American Cooperative Oncology Group | 43 | 2020-03-05 | 2024-02-20 |
| CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg - Breast Cancer | Phase 2 | Withdrawn | Weill Medical College of Cornell University | 2020-03-04 | 2020-09-21 | |
| 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 |
| Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer Palbociclib 75mg, Letrozole 2.5mg, T-DM1 - HER2-positive Breast Cancer, Breast Cancer Metastatic | Phase 1 / Phase 2 | Terminated | University of Kansas Medical Center | 3 | 2018-10-15 | 2024-03-05 |
| Histology-Independent Study of Palbociclib in Patients With Advanced Cancer Palbociclib 125mg - Cancer, Advanced | Phase 2 | Withdrawn | Razelle Kurzrock, MD | 2018-07-01 | 2018-06-21 | |
| Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant Fulvestrant 500mg, Palbociclib 125mg, Goserelin 3.6 MG - Breast Neoplasm Female | Phase 3 | Completed | International Cancer Research Group, United Arab Emirates | 354 | 2017-12-20 | 2023-03-10 |
| PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection Palbociclib 125mg, Aromatase Inhibitors, Fulvestrant Injectable Product - Metastatic Breast Cancer | Phase 3 | Completed | UNICANCER | 1017 | 2017-03-22 | 2025-11-18 |
| Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer Palbociclib 100mg, Palbociclib 125mg, Fulvestrant or Tamoxifen or Aromatase Inhibitor - Breast Cancer | Phase 2 | Completed | Canadian Cancer Trials Group | 180 | 2016-04-08 | 2026-04-13 |
| 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 Palbociclib 75mg, Palbociclib 125mg, Palbociclib 100mg - Healthy | Phase 1 | Completed | Pfizer | 27 | 2014-03-01 | 2014-06-24 |
| PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma Palbociclib 200mg, Palbociclib 125mg - Sarcoma, Liposarcoma | Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 90 | 2010-09-23 | 2017-11-06 |
Breast Neoplasms (11) · Neoplasms (2) · Ovarian Neoplasms (2) · Colorectal Neoplasms (1) · Inflammation (1) · Liposarcoma (1) · Lung Neoplasms (1) · Sarcoma (1)
Weill Medical College of Cornell University (2) · American Society of Clinical Oncology (1) · Canadian Cancer Trials Group (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · ETOP IBCSG Partners Foundation (1) · Forward Pharmaceuticals Co., Ltd. (1) · International Cancer Research Group, United Arab Emirates (1) · Latin American Cooperative Oncology Group (1) · Lebanese University (1) · MedSIR (1) · Megalabs (1) · Memorial Sloan Kettering Cancer Center (1) · Pfizer (1) · Razelle Kurzrock, MD (1) · Relay Therapeutics, Inc. (1)
United States (8) · France (4) · Italy (3) · Spain (3) · China (2) · Lebanon (2) · Algeria (1) · Australia (1) · Austria (1) · Brazil (1) · Canada (1) · Czechia (1) · Egypt (1) · Germany (1) · Hungary (1)
Silvia Formenti, M.D. (2) · Amulya Yellala, MBBS (1) · Anil A. Joy (1) · Antonio Llombart (1) · Elisabetta Munzone, MD (1) · Fernanda Bronzon Damian (1) · Jean-Marc Nabholtz, MD (1) · Julie Gralow, MD (1) · Lauren Nye, MD (1) · M Gowtham, MD (1) · Mark Dickson, MD (1) · Nehman Makdissy, Professor (1) · Ning Li, Doctor (1)
PMID 23569312, PMID 27124835, PMID 32641862, PMID 34083331, PMID 35241469, PMID 36183733, PMID 36680581, PMID 41123599
2016 (1), 2018 (1)