A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04031885|
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Abemaciclib Drug: Fulvestrant Drug: Standard Chemotherapy||Phase 4|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases|
|Actual Study Start Date :||August 14, 2019|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||December 15, 2022|
Experimental: Abemaciclib + Fulvestrant
Abemaciclib given orally and fulvestrant given by intramuscular (IM) injection.
Other Name: LY2835219
Active Comparator: Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.
Drug: Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label
- Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 31 Months) ]ORR
- Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 31 Months) ]PFS
- Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 31 Months) ]TTR
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 31 Months) ]DoR
- PFS 2 [ Time Frame: Baseline to Second Objective Progression or Death Due to Any Cause (Estimated up to 62 Months) ]PFS 2
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): NCT04031885
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.email@example.com|
|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|