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Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY

NCT01942135•Pfizer

View on ClinicalTrials.gov

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
•Confirmed diagnosis of HR+/HER2- breast cancer
•Any menopausal status
•Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
•On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
•Measurable disease defined by RECIST version 1.1, or bone-only disease
•Eastern Cooperative Oncology Group (ECOG) PS 0-1
•Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
•Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria

•Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
•Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
•Major surgery or any anti-cancer therapy within 2 weeks of randomization
•Prior stem cell or bone marrow transplantation
•Use of potent CYP3A4 inhibitors or inducers

Locations (247)

University of Alabama at Birmingham, The Kirklin Clinic

Birmingham, Alabama, United States

UAB Hospital-Investigational Drug Service

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Southern Cancer Center, PC

Daphne, Alabama, United States

Southern Cancer Center, PC

Mobile, Alabama, United States

Southern Cancer Center, PC

Mobile, Alabama, United States

Southern Cancer Center,PC

Mobile, Alabama, United States

Arizona Center for Cancer Care

Avondale, Arizona, United States

Ironwood Physicians P.C dba Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Arizona Oncology Associates, PC- HAL

Flagstaff, Arizona, United States

Key Dates

Start Date

September 26, 2013

Primary Completion Date

December 5, 2014

Completion Date

September 28, 2022

Last Updated

April 4, 2024

Enrollment

521

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Palbociclib

DRUG

Fulvestrant

DRUG

Placebo

DRUG

Fulvestrant

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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