Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297438
Recruitment Status : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Palbociclib Drug: Letrozole Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF PREVIOUSLY UNTREATED ASIAN POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) ADVANCED BREAST CANCER
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Palbociclib + Letrozole
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)
Drug: Palbociclib
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Other Name: PD-0332991

Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)

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

Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ]
    Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From start of study treatment up to 6 years ]
    Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

  2. Number of Participants With Objective Response [ Time Frame: Baseline up to 2.5 years ]
    Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those that [enter definition from protocol].

  3. Duration of Response (DR) [ Time Frame: Baseline up to 2.5 years ]
    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  4. Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Week X [ Time Frame: Baseline up to 2.5 years ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  5. FACT-B [ Time Frame: Baseline up to 2.5 years ]
    Change From Baseline in Functional Assessment of Cancer therapy -Breast (FACT-B)

  6. Expression/alteration/change of tumor tissue biomarkers [ Time Frame: Baseline, 24 months ]
    including genes, proteins, and RNA expression (eg, ER, Ki67).

  7. Probability of Participant Survival [ Time Frame: From start of study treatment to 3 years ]
    Probability of survival 1-year, 2- and 3-years after the first dose of study treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297438


Locations
Show Show 55 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02297438    
Other Study ID Numbers: A5481027
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
breast cancer
postmenopausal women
estrogen-receptor positive
HER2 negative
locoregionally recurrent
metastatic
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors