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

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a combination of letrozole and palbociclib in postmenopausal women with a specific type of advanced breast cancer. Letrozole reduces estrogen levels, which can slow cancer growth, while palbociclib stops cancer cells from dividing. The goal is to see if this combination works better than letrozole alone.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) as Assessed by the Investigator

Secondary study objectives

Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)

Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PD-0332991 + LetrozoleExperimental Treatment2 Interventions

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 II: Placebo + LetrozoleActive Control2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3590

PD-0332991

2013

Completed Phase 3

~1200