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

• Status: Active, not recruiting
• Trial end date: 2023-08-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Letrozole; Palbociclib

Criteria

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.