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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Placebo; Drug: PD-0332991; Drug: Letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740427

2012-004601-27 (EudraCT Number)

PALOMA-2 (Other Identifier)

A5481008

PALMOA-2 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 666 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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666 participants in 2 patient groups

PD-0332991 + Letrozole

Experimental group

Description:

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).

Treatment:

Drug: Letrozole

Drug: Letrozole

Drug: PD-0332991

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: Letrozole

Drug: Placebo