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Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEII)
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|ClinicalTrials.gov Identifier: NCT04432454|
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sermonix Pharmaceuticals Inc.
Information provided by (Responsible Party):
Sermonix Pharmaceuticals Inc.
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Lasofoxifene and abemaciclib (VERZENIO (R).||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII )|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||October 2022|
Women who have locally advanced or metastatic ER+/HER2- breast cancer and disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation
Drug: Lasofoxifene and abemaciclib (VERZENIO (R).
Lasofoxifene 5 mg given once a day orally and 150 mg of abemaciclib given twice a day orally.
Primary Outcome Measures :
- Safety and tolerability of the combination of lasofoxifene and abemaciclib as measured by number of adverse events (AEs), severity of AEs and mortality due to AEs at every scheduled visit. [ Time Frame: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. Safety and tolerability will be assessed from enrollment up to 24 months. ]AEs will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Secondary Outcome Measures :
- Progression free survival (PFS) [ Time Frame: Up to 24 months ]PFS is defined as the time from the date of entry into the study to the earliest date of first documented progression or death due to any cause.
- Clinical benefit rate (CBR) [ Time Frame: 24 weeks or longer ]
- Objective response rate (ORR) [ Time Frame: All subjects enrolled in the study will be treated until documented disease progression or until withdrawal for any reason. ORR will be assessed up to 24 months. ]
- Duration of response (DoR) [ Time Frame: DoR will be assessed up to 24 months. ]DoR is from the date of first documented response (CR or PR) to the date of first documented progression of disease or death due to any cause.
- Time to response [ Time Frame: Time to response will be assessed up to 24 months. ]From the date of entry into the study to the date of first documented response (CR or PR).
- Steady-state pharmacokinetics (PK) sampling for lasofoxifene and abemaciclib concentrations as well as abemaciclib's 3 major metabolites of lasofoxifene and abemaciclib [ Time Frame: Baseline and pre-dose at every visit starting at Visit 0 (Day 1) through Visit 4 (Week 8) and at the Final/ET visit if this occurred prior to Week 8 ]
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