A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Pfizer

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Placebo; Drug: Letrozole; Drug: Palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02297438

A5481027

Details and patient eligibility

About

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

Enrollment: 340 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Asian 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] 0-1
• 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 neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
• Prior treatment with any CDK 4/6 inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups

Palbociclib + Letrozole

Experimental group

Description:

Palbociclib, 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)

Treatment:

Drug: Letrozole

Drug: Palbociclib

Drug: Letrozole

Placebo + Letrozole

Active Comparator group

Description:

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).

Treatment:

Drug: Letrozole

Drug: Placebo

Drug: Letrozole