Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
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|ClinicalTrials.gov Identifier: NCT02600923|
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : May 21, 2020
Last Update Posted : June 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer Female||Drug: Palbociclib Drug: Letrozole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Masking:||None (Open Label)|
|Official Title:||STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE|
|Actual Study Start Date :||April 15, 2016|
|Actual Primary Completion Date :||May 28, 2019|
|Actual Study Completion Date :||May 28, 2019|
Experimental: Palbociclib + Letrozole
palbociclib and letrozole combination
Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1).
Other Name: Ibrance
Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
Other Name: Femara
- Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 3 years ]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 TEAE. 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.
- Number of Participants With Palbociclib-related TEAEs [ Time Frame: 3 years ]An 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 TEAE. AE severity was graded according to 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. Palbociclib-related TEAEs were determined by the investigator.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 3 years ]An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. Palbociclib-related SAEs were determined by the investigator.
- Number of Participants With Death [ Time Frame: 3 years ]Death from any cause while on treatment and within 28 days of palbociclib discontinuation was only counted below.
- The Objective Response Rate (ORR) [ Time Frame: 3 years ]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.
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): NCT02600923
|Study Director:||Pfizer CT.gov Call Center||Pfizer|