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Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Status: Recruiting

The goal of this study is to evaluate the effectiveness of elacestrant compared to standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ER-positive, HER2-negative breast cancer without evidence of recurrence or distant metastases
• considered to be at high risk when cancer was initially diagnoses
• have received at least 24 months but not more than 60 months of endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• inflammatory breast cancer
• history of prior invasive breast cancer
• history of another cancer in the past 3 years
• have had more than a 6-month continuous interruption of endocrine therapy or who are off currently off endocrine therapy more than 6 months
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:

Drug: Anastrozole, Drug: Elacestrant, Drug: Exemestane, Drug: Letrozole, Drug: Tamoxifen

Conditions:

Cancer

Keywords:

Breast Cancer

Study Contact: Kristen Nelson - knelso65@fairview.org
Principal Investigator: Kiran Lassi
Phase: PHASE3
IRB Number: MMCORC097
See this study on ClinicalTrials.gov

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