Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
Completed · Phase 3 · Has a placebo group
Conditions studied: Metastatic Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT01942135
- Run by
- Pfizer
- People needed
- 521
- Starts
- 2013-09-26
- Expected to finish
- 2022-09-28
- Last updated by the study team
- 2024-04-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Ironwood Physicians P.C dba Ironwood Cancer & Research Centers — Gilbert, Arizona, United States
- Palo Verde Hematology Oncology — Glendale, Arizona, United States
- Arizona Center for Cancer Care — Glendale, Arizona, United States
- Western Regional Medical Center, Inc. — Goodyear, Arizona, United States
- Ironwood Physicians P.C dba Ironwood Cancer & Research Centers — Mesa, Arizona, United States
- Ironwood Physicians P.C dba Ironwood Cancer & Research Centers — Mesa, Arizona, United States
- Arizona Oncology Associates, PC- HAL — Prescott Valley, Arizona, United States
- Arizona Oncology Associates, PC- HAL — Sedona, Arizona, United States
- Arizona Center for Cancer Care — Surprise, Arizona, United States
- The University of Arizona Cancer Center- North Campus — Tucson, Arizona, United States
- The University of Arizona Cancer Center — Tucson, Arizona, United States
- CBCC Global Research Inc. at Comprehensive Blood and Cancer Center — Bakersfield, California, United States
- Administrative Management Only: Translational Research Management — Culver City, California, United States
- City of Hope — Duarte, California, United States
- St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
- University of Alabama at Birmingham, The Kirklin Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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