Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments palbociclib, fulvestrant, placebo
Phase phase 3
Target CDK4
Sponsor Pfizer
Collaborator AstraZeneca
Start date September 2013
End date December 2014
Trial size 427 participants
Trial identifier NCT01942135, 2013-002580-26, A5481023

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
palbociclib
Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
(Active Comparator)
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
placebo
Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.

Primary Outcomes

Measure
Progression-Free Survival
time frame: Baseline up to approximately 10 months

Secondary Outcomes

Measure
Overall Survival
time frame: Baseline until death (up to approximately 28 months)
Objective Response
time frame: Baseline until approximately 10 months
Duration of Response
time frame: Baseline up to approximately 10 months
Clinical Benefit Response (CBR)
time frame: Baseline up to approximately 10 months
1 Year Probability of Participant Survival
time frame: From baseline through 1 year
2 Year Probability of Participant Survival
time frame: From baseline through 2 years
3 Year Probability of Participant Survival
time frame: From baseline through 3 years
Minimum Observed Plasma Trough Concentration (Cmin)
time frame: Cycles 1 and 2
Alterations in genes, proteins, and ribonucleic acids relevant to the cell cycle, drug targets, tumor sensitivity and/or resistance
time frame: From baseline until approximately 10 months
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
time frame: From baseline through approximately month 10
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
time frame: From baseline through approximately month 10
European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ BR23)
time frame: From baseline through approximately month 10
Time to Deterioration (TTD)
time frame: From baseline through approximately month 10
Minimally Important Difference Cut-Off
time frame: From baseline through approximately month 10

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Pfizer.