Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)
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|ClinicalTrials.gov Identifier: NCT05169567|
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : June 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Neoplasm Metastasis||Drug: Abemaciclib Drug: Fulvestrant Drug: Placebo||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy|
|Actual Study Start Date :||March 11, 2022|
|Estimated Primary Completion Date :||August 4, 2023|
|Estimated Study Completion Date :||February 16, 2026|
Experimental: Arm A: Abemaciclib plus Fulvestrant
Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
Active Comparator: Arm B: Placebo plus Fulvestrant
Placebo administered orally in combination with fulvestrant administered IM.
- Progression-Free Survival (PFS) [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) ]Investigator assessment
- Overall Survival (OS) [ Time Frame: Randomization until death from any cause (estimated as up to 5 years) ]OS
- PFS [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years) ]Blinded independent review
- Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]ORR
- Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]CBR
- Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD) [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years) ]DoR
- Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [ Time Frame: Randomization through Follow-up (estimated as up to 3 years) ]The mBPI-sf "Worst pain" is a single self-reported item that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
- Time to Deterioration in Physical Function [ Time Frame: Randomization through Follow-up (estimated as up to 3 years) ]Physical Function scale includes five items (trouble with strenuous activities; trouble with long walk; trouble with short walk; need to stay in bed or chair; need help with eating, dressing, washing, toilet) in the European Organization for Research and Treatment of Cancer Item Library 19 (EORTC-19). Response options range from 0 ("not all") to 4 ("very much.") Higher composite scale scores indicate higher function.
- Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib [ Time Frame: Day 1 of Cycle 3 (Cycle = 28 days) ]PK: Mean Steady State Concentrations of Abemaciclib
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): NCT05169567
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.firstname.lastname@example.org|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|