Palbociclib 125mg

DRUG19 trials

Sponsors

Memorial Sloan Kettering Cancer Center, Pfizer, Canadian Cancer Trials Group, UNICANCER, Razelle Kurzrock, MD

Conditions

Advanced Breast CancerBioequivalenceBreast CancerBreast Cancer MetastaticBreast Cancer RecurrentBreast Cancer Stage IBreast Cancer Stage IIBreast Neoplasm Female

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

CompletedNCT02059330

Start: 2014-03-31End: 2014-06-30Updated: 2014-06-24

Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

TerminatedNCT03709082

University of Kansas Medical CenterBreast Cancer Metastatic, HER2-positive Breast Cancer

Start: 2018-10-15End: 2021-02-03Updated: 2024-03-05

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

RecruitingNCT05216432

Relay Therapeutics, Inc.Advanced Breast Cancer, Breast Cancer, HER2-negative Breast Cancer +4

Start: 2021-12-08End: 2027-04-30Target: 930Updated: 2025-09-22

Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

RecruitingNCT06307249

Lebanese UniversityBreast Cancer, Cancer, Chemotherapy +7

Start: 2023-02-15End: 2027-12-31Target: 50Updated: 2024-03-12

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

RecruitingNCT07002177

Forward Pharmaceuticals Co., Ltd.Breast Cancer Stage I, Breast Cancer Stage II, ER+ Breast Cancer +2

Start: 2025-06-01End: 2028-11-01Target: 196Updated: 2026-01-07

Phase 2

PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

CompletedNCT01209598

Memorial Sloan Kettering Cancer CenterLiposarcoma, Sarcoma

Start: 2010-09-23End: 2016-10-25Updated: 2017-11-06

Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer

CompletedNCT02630693

Canadian Cancer Trials GroupBreast Cancer

Start: 2016-04-08End: 2023-11-29Updated: 2025-11-25

Histology-Independent Study of Palbociclib in Patients With Advanced Cancer

WithdrawnNCT03123744

Razelle Kurzrock, MDCancer, Advanced

Start: 2018-07-01End: 2024-02-01Updated: 2018-06-21

Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer

CompletedNCT03936270

Latin American Cooperative Oncology GroupOvarian Cancer

Start: 2020-03-05End: 2023-05-02Updated: 2024-02-20

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

WithdrawnNCT04220476

Weill Medical College of Cornell UniversityBreast Cancer

Start: 2020-03-04End: 2028-12-31Updated: 2020-09-21

PLATFORM Study of Precision Medicine for Rare Tumors

RecruitingNCT04423185

Cancer Institute and Hospital, Chinese Academy of Medical SciencesRare Tumor

Start: 2020-08-15End: 2028-07-01Target: 770Updated: 2025-02-11

Combined Immunotherapies in Metastatic ER+ Breast Cancer

RecruitingNCT04563507

Weill Medical College of Cornell UniversityBreast Cancer

Start: 2020-11-12End: 2028-10-31Target: 102Updated: 2025-12-15

Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

Active, not recruitingNCT05069038

University of NebraskaBreast Cancer

Start: 2022-03-02End: 2032-09-30Updated: 2025-12-22

Phase 3

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

CompletedNCT03079011

UNICANCERMetastatic Breast Cancer

Start: 2017-03-22End: 2025-09-22Updated: 2025-11-18

Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

CompletedNCT03447132

International Cancer Research Group, United Arab EmiratesBreast Neoplasm Female

Start: 2017-12-20End: 2021-07-20Updated: 2023-03-10

Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer

Active, not recruitingNCT03820830

ETOP IBCSG Partners FoundationBreast Cancer Recurrent

Start: 2019-08-27End: 2029-01-01Updated: 2025-03-07

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

RecruitingNCT06377852

American Society of Clinical OncologyMetastatic Breast Cancer

Start: 2024-10-29End: 2028-09-01Target: 500Updated: 2026-03-18

Phase 4

Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg

CompletedNCT06331715

MegalabsBioequivalence

Start: 2024-02-06End: 2024-05-31Updated: 2024-08-19

Unknown Phase

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

CompletedNCT06525675

MedSIRAdvanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer +2

Start: 2022-07-18End: 2024-09-02Updated: 2024-12-13

Related Papers

Abstract PD10-07: Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD

Clinical Cancer Research2026-02-17

Abstract PS5-07-08: CDK4/6 inhibitor (CDK4/6i) dosing knowledge (CDK) study: A pragmatic randomized trial of indicated vs. titrated CDK4/6i dosing in older adults with HR+/HER2- metastatic breast cancer (MBC)

Clinical Cancer Research2026-02-17

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Abstract P3-04-18: An immunological mechanism of resistance to CDK4/6 inhibitors in breast cancer

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Overall survival from the open label phase 2 trial of palbociclib in patients with advanced well differentiated/dedifferentiated liposarcoma.

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Dynamics and type of <i>ESR1</i> mutations under aromatase inhibitor or fulvestrant combined with palbociclib after randomization in the PADA-1 trial.

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A phase II trial of palbociclib combined to letrozole after progression on second-line chemotherapy for women with ER/PR-positive high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer: LACOG 1018.

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Abstract P5-02-27: Serum thymidine kinase activity as a prognostic marker in women with metastatic breast cancer treated with two different schedules of palbociclib plus second-line endocrine therapy within the CCTG MA38 trial

Cancer Research2023-03-01

Neoadjuvant endocrine therapy with or without palbociclib in low-risk patients: a phase III randomized double-blind SAFIA trial.

2023-01-2112 citations

TP040/#1418 Palbociclib plus letrozole combination after progression on second-line chemotherapy for women with ER/PR-positive high-grade serous or endometrioid ovarian, fallopian tube or peritoneal cancer (LACOG 1018)

2022-12-01

Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial.

2022-09-29215 citations

First-in-human global multi-center study of RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, as a single agent in patients with advanced solid tumors and in combination with fulvestrant in patients with advanced breast cancer.

Journal of Clinical Oncology2022-06-014 citations

Final result for SAFIA trial for neoadjuvant palbociclib in patients with operable luminal breast cancer responding to fulvestrant.

Journal of Clinical Oncology2022-06-014 citations

Real-Time Detection of ESR1 Mutation in Blood by Droplet Digital PCR in the PADA-1 Trial: Feasibility and Cross-Validation with NGS

Analytical Chemistry2022-04-1325 citations

26 more papers not shown