Description:
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.
Title
- Brief Title: 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]
- 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
Clinical Trial IDs
- ORG STUDY ID:
A5481027
- NCT ID:
NCT02297438
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Palbociclib | PD-0332991 | Palbociclib + Letrozole |
| Letrozole | | Palbociclib + Letrozole |
| Placebo | | Placebo + Letrozole |
| Letrozole | | Placebo + Letrozole |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Palbociclib + Letrozole | Experimental | 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) | |
| 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). | |
Eligibility 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
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression-Free Survival (PFS) |
| Time Frame: | Baseline up to 2.5 years |
| Safety Issue: | |
| Description: | 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
| Measure: | Overall Survival (OS) |
| Time Frame: | From start of study treatment up to 6 years |
| Safety Issue: | |
| Description: | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. |
| Measure: | Number of Participants With Objective Response |
| Time Frame: | Baseline up to 2.5 years |
| Safety Issue: | |
| Description: | 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]. |
| Measure: | Duration of Response (DR) |
| Time Frame: | Baseline up to 2.5 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Week X |
| Time Frame: | Baseline up to 2.5 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | FACT-B |
| Time Frame: | Baseline up to 2.5 years |
| Safety Issue: | |
| Description: | Change From Baseline in Functional Assessment of Cancer therapy -Breast (FACT-B) |
| Measure: | Expression/alteration/change of tumor tissue biomarkers |
| Time Frame: | Baseline, 24 months |
| Safety Issue: | |
| Description: | including genes, proteins, and RNA expression (eg, ER, Ki67). |
| Measure: | Probability of Participant Survival |
| Time Frame: | From start of study treatment to 3 years |
| Safety Issue: | |
| Description: | Probability of survival 1-year, 2- and 3-years after the first dose of study treatment |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Pfizer |
Trial Keywords
- breast cancer
- postmenopausal women
- estrogen-receptor positive
- HER2 negative
- locoregionally recurrent
- metastatic
Last Updated
June 10, 2021
