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A Study of Palbociclib (PD-03...

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Last Updated: 2024-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

666 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-22

Study Completion Date

2023-11-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PD-0332991 + Letrozole

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).

Group Type EXPERIMENTAL

PD-0332991

Intervention Type DRUG

PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Letrozole

Intervention Type DRUG

Letrozole, 2.5mg, orally once daily (continuously)

Placebo + Letrozole

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).

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Letrozole

Intervention Type DRUG

Letrozole, 2.5mg, orally once daily (continuously)

Interventions

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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

Intervention Type DRUG

Letrozole

Letrozole, 2.5mg, orally once daily (continuously)

Intervention Type DRUG

Placebo

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Intervention Type DRUG

Letrozole

Letrozole, 2.5mg, orally once daily (continuously)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Southern California Permanente Medical Group

Bellflower, California, United States

Site Status

Beverly Hills Cancer Center

Beverly Hills, California, United States

Site Status

St. Joseph Heritage Healthcare

Fullerton, California, United States

Site Status

Los Angeles Hematology/Oncology Medical Group

Glendale, California, United States

Site Status

UCLA Hematology/ Oncology- Irvine

Irvine, California, United States

Site Status