NCT01740427|CompletedPhase 3ResultsDMC

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

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

Pfizer ClinicalTrials.gov

Compare

4 other identifiers

A54810082012-004601-27PALMOA-2PALOMA-2

Study Type

interventional

Target

666

Locations

18 countries

Sites

305

Timeline

RegisteredDec 2012

StartedFeb 2013

CompletionNov 2023

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

666

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Feb 2013

Longer than P75 for phase_3

Geographic Reach

18 countries

305 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.7 years study duration

First Submitted

Initial submission to the registry

November 26, 2012

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

February 22, 2013

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2017

Completed

6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2023

Completed

Last Updated

November 14, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

November 26, 2012

Results QC Date

October 21, 2016

Last Update Submit

October 22, 2024

Conditions

Breast Neoplasms

Keywords

breast cancerpostmenopausal womenestrogen-receptor positiveHER2 negativelocoregionally recurrentmetastaticPalbociclib (PD-0332991)PALOMA-2

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival (PFS) as Assessed by the Investigator
PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.
From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)

Secondary Outcomes (15)

Objective Response as Assessed by the Investigator
From randomization until end of treatment (up to approximately 2.5 years)
Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator
From randomization until end of treatment (up to approximately 2.5 years)
Duration of Response (DR)
From randomization until end of treatment (up to approximately 2.5 years)
Disease Control (DC)/Clinical Benefit Response (CBR)
From randomization until end of treatment (up to approximately 2.5 years)
PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
From randomization until end of treatment (up to approximately 24 Months)
+10 more secondary outcomes

Study Arms (2)

PD-0332991 + Letrozole

EXPERIMENTAL

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).

Drug: PD-0332991Drug: Letrozole

Placebo + Letrozole

ACTIVE COMPARATOR

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).

Drug: PlaceboDrug: Letrozole

Interventions

PD-0332991DRUG

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

PD-0332991 + Letrozole

LetrozoleDRUG

Letrozole, 2.5mg, orally once daily (continuously)

PD-0332991 + Letrozole

PlaceboDRUG

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

Placebo + Letrozole

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (305)

Southern California Permanente Medical Group

Bellflower, California, 90706, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

St. Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

Los Angeles Hematology/Oncology Medical Group

Glendale, California, 91206, United States

Location

UCLA Hematology/ Oncology- Irvine

Irvine, California, 92604, United States

Location

UCLA Hematology Oncology- Laguna Hills

Laguna Hills, California, 92653, United States

Location

Los Angeles Hematology/Oncology Medical Group

Los Angeles, California, 90017, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

Location

Translational Research Management

Los Angeles, California, 90045, United States

Location

Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

Los Angeles, California, 90095-1772, United States

Location

UCLA West Medical Pharmacy, Attn: Steven L. Wong

Los Angeles, California, 90095-7349, United States

Location

UCLA West Medical Pharmacy: Drug Management Only

Los Angeles, California, 90095-7349, United States

Location

UCLA West Medical Pharmacy; Drug Management Only

Los Angeles, California, 90095-7349, United States

Location

UCLA West Medical Pharmacy

Los Angeles, California, 90095-7349, United States

Location

Administrative Address: UCLA Hematology/Oncology