Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04791384|
Recruitment Status : Not yet recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Abemaciclib Drug: Elacestrant||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||June 2023|
Abemaciclib and Elacestrant combination
- The number of patients in Phase 1b part of the study with any adverse events (AE). [ Time Frame: 1.5 years ]To determine the safety and tolerability of the abemaciclib and elacestrant combination. We will assess the incidence, nature and severity of all adverse events (AE) that occur on or after C1D1 of therapy, AE severities will be classified using the CTCAE criteria.
- Assess the efficacy of the drug combination abemaciclib and elacestrant. [ Time Frame: The whole study- 2.5 years ]Determine the overall intracranial response rate (OIRR; complete and partial response) and clinical benefit rate (CBR) as defined by brain metastasis response criteria (RANO-BM) in women with HR+ / Her2- breast cancer using the sum of study participants who experience complete response or partial response within 24 weeks or less. This assessment will look at tumor responses conducted before patients start treatment, at timepoints while receiving treatment, and at treatment end.
- Evaluate tumor response rates of treatment with abemaciclib and elacestrant combination. [ Time Frame: 2.5 years ]Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. tumor responses conducted before patients start treatment, at timepoints while they receive treatment, and when their treatment ends, will be evaluated.
- Evaluate duration of tumor response rates of treatment with abemaciclib and elacestrant combination. [ Time Frame: 2.5 years ]Duration of intracranial benefit rate will be measured per the response assessment in neuro-oncology brain metastases (RANO-BM) for the time of participation in the study.
- The percentage of patients to complete the study. [ Time Frame: 2.5 years ]Study participants will be followed for the duration of their participate in the study for overall survival.
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): NCT04791384
|Contact: Kari Andersonfirstname.lastname@example.org|
|Principal Investigator:||Peter Kabos, MD||University of Colorado, Denver|