ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (ELCIN)
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|ClinicalTrials.gov Identifier: NCT05596409|
Recruitment Status : Recruiting
First Posted : October 27, 2022
Last Update Posted : November 29, 2023
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Elacestrant||Phase 2|
This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.
The study duration for each patient is estimated to be:
- Screening Phase: Up to 21 days prior to Cycle 1, Day 1 (C1/D1);
- Treatment Phase: From C1/D1 until the date of radiologically documented progression, or treatment discontinuation due to other reasons.
- Survival Follow-Up Phase: All patients will be followed for survival approximately every 3 months up to 24 months after enrollment of the last patient.
Patients will be followed for AEs for 28 days after the last treatment administration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)|
|Actual Study Start Date :||May 19, 2023|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||August 2025|
Subjects will take a starting dose of 400 mg of elacestrant dihydrochloride in tablet form once daily for up to 6 months.
Starting dose 400 mg elacestrant dihydrochloride administered orally once daily for an estimated 6 months of treatment.
- Progression-free survival rate [ Time Frame: 6 months ]Rate is defined as percentage of subjects achieving progression-free survival, defined as time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first.
- Overall response rate [ Time Frame: 24 months ]Proportion of patients who achieve a best overall response of partial response or complete response
- Duration of response [ Time Frame: 36 months ]Time from the date of first documented complete response or partial response until the first radiological documentation of disease progression or death, whichever comes first
- Clinical benefit rate [ Time Frame: 36 months ]Proportion of patients who achieve a best overall response of confirmed complete response or partial response or durable stable disease (duration at least 24 weeks from date of first dose)
- Overall survival [ Time Frame: 36 months ]Time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first
- Progression-free survival [ Time Frame: 36 months ]Time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first
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): NCT05596409
|Contact: Stemline Trialsemail@example.com|
|United States, Arkansas|
|Springdale, Arkansas, United States, 72762|
|Contact: Thaddeus Beck|
|United States, California|
|Arcadia, California, United States, 91007|
|Contact: Anthony Lam|
|United States, Florida|
|Morton Plant Hospital - Baycare Health System||Recruiting|
|Clearwater, Florida, United States, 33756|
|Contact: Vijaya Gadiyaram|
|United States, Nevada|
|Comprehensive Cancer Centers of Nevada||Recruiting|
|Las Vegas, Nevada, United States, 89128|
|Contact: Anu Thummala|
|United States, Ohio|
|The Toledo Clinic||Recruiting|
|Toledo, Ohio, United States, 43606|
|Contact: Jennifer Martinez 419-479-5605|
|Contact: Julianne Hortsman 419-479-5605|
|Principal Investigator: Rex Mowat|