Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatments pd-0332991, letrozole, placebo
Phase phase 3
Target CDK4
Sponsor Pfizer
Start date February 2013
End date February 2016
Trial size 650 participants
Trial identifier NCT01740427, 2012-004601-27, A5481008

Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

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, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
pd-0332991
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
letrozole
Letrozole, 2.5mg, orally once daily (continuously)
(Active Comparator)
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
letrozole
Letrozole, 2.5mg, orally once daily (continuously)

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: Baseline up to 2.5 years

Secondary Outcomes

Measure
Probability of Participant Survival
time frame: From start of study treatment up to 6 years
Overall Survival (OS)
time frame: Baseline to date of death from any cause (up to 6 years)
Objective Response (OR)
time frame: Baseline up to 2.5 years
Duration of Response (DR)
time frame: Baseline up to 2.5 years
Disease Control (DC)
time frame: Baseline up to 2.5 years
QTc interval
time frame: Baseline and Day 14 of Cycle 1
Minimum Observed Plasma Trough Concentration (Cmin)
time frame: Day 14 of cycles 1 and 2
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week X
time frame: Baseline up to 2.5 years
Change From Baseline in Functional Assessment od Cancer therapy -Breast (FACT-B) at Week X
time frame: Baseline up to 2.5 years
Tumor tissue biomarkers
time frame: Baseline, 24 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. - Confirmed diagnosis of ER positive breast cancer - No prior systemic anti-cancer therapy for advanced ER+ disease. - Postmenopausal women - Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease - Eastern Cooperative Oncology Group [ECOG] 0-2 - Adequate organ and marrow function - Patient must agree to provide tumor tissue Exclusion Criteria: - Confirmed diagnosis of HER2 positive disease - Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term - Known uncontrolled or symptomatic CNS metastases - Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment. - Prior treatment with any CDK 4/6 inhibitor.

Additional Information

Official title A Randomized, Multicenter, Double-blind Phase 3 Study Of Pd-0332991 (Oral Cdk 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With Er (+), Her2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti Cancer Treatment For Advanced Disease
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.