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

• Status: Active, not recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: AstraZeneca
• Treatments: Estradiol; Fulvestrant; Goserelin; Hormones; Palbociclib

Criteria

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