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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Placebo; Drug: Fulvestrant; Drug: Palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01942135

2013-002580-26 (EudraCT Number)

A5481023

Details and patient eligibility

About

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).

Enrollment: 521 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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521 participants in 2 patient groups

Arm A

Experimental group

Description:

Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.

Treatment:

Drug: Fulvestrant

Drug: Fulvestrant

Drug: Palbociclib

Arm B

Active Comparator group

Description:

Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.

Treatment:

Drug: Fulvestrant

Drug: Placebo

Drug: Fulvestrant