Description:
A study of palbociclib in combination with letrozole as treatment of post-menopausal women
with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole
therapy is deemed appropriate.
Title
- Brief Title: Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
- Official Title: A STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
Clinical Trial IDs
- ORG STUDY ID:
A5481037
- NCT ID:
NCT02679755
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Palbociclib | IBRANCE | Experimental arm |
| Letrozole | | Experimental arm |
Purpose
A study of palbociclib in combination with letrozole as treatment of post-menopausal women
with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole
therapy is deemed appropriate.
Detailed Description
To provide access to palbociclib to post-menopausal patients with hormone receptor-positive
[HR(+)], HER2-negative [HER2(-)] ABC who are deemed appropriate for letrozole therapy.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Experimental arm | Experimental | Palbociclib plus Letrozole | |
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma
of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole
therapy (in the first-line advanced/metastatic disease setting).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow, liver, and renal function.
Exclusion Criteria:
- Prior treatment with any CDK inhibitor .
- QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc
prolongation, or Torsade de Pointes.
- High cardiovascular risk, including, but not limited to myocardial infarction,
severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary
embolism in the past 6 months of enrollment.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) |
| Time Frame: | Baseline up to 28 days after last dose of study treatment, an average of 14 months |
| Safety Issue: | |
| Description: | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary Outcome Measures
| Measure: | Percentage of Participants With Complete Response and Partial Response |
| Time Frame: | Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year |
| Safety Issue: | |
| Description: | Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied. |
| Measure: | The Objective Response Rate (ORR) |
| Time Frame: | Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year |
| Safety Issue: | |
| Description: | The tumor response was based on the response reported by investigator per local practice. No response confirmation was applied. ORR was defined as the percentage of participants with complete response or partial response relative to all as-treated population. |
| Measure: | EQ-5D Health Utility Index Score |
| Time Frame: | The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline. |
| Safety Issue: | |
| Description: | The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The first part was a 5 item questionnaire designed to assess health status in terms of a single index value or utility score. It consisted of 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A respondent was asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. The answers given to the 5 descriptors permit to find 243 unique health states which can be converted into a single EQ-5D index value by published algorithms. For the EQ-5D index, published weights are available that allow for the creation of a summary score ranging from -0.594 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. |
| Measure: | Change From Baseline in EQ-5D Health Utility Index Score |
| Time Frame: | The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline. |
| Safety Issue: | |
| Description: | The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The first part was a 5 item questionnaire designed to assess health status in terms of a single index value or utility score. It consisted of 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A respondent was asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. The answers given to the 5 descriptors permit to find 243 unique health states which can be converted into a single EQ-5D index value by published algorithms. For the EQ-5D index, published weights are available that allow for the creation of a summary score ranging from -0.594 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. |
| Measure: | EQ-VAS Score |
| Time Frame: | The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline. |
| Safety Issue: | |
| Description: | The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The second part consisted of a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) |
| Measure: | Change From Baseline in EQ-VAS Score |
| Time Frame: | The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline. |
| Safety Issue: | |
| Description: | The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The second part consisted of a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) |
Details
| Phase: | Phase 4 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Pfizer |
Trial Keywords
- Hormone receptor positive advanced breast cancer
Last Updated
August 17, 2021
