This study is currently not recruiting participants.

Phase III Randomized Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

Investigating the Effectiveness of Hormone Therapy with or without an Additional Treatment for Breast Cancer

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

Detailed description of study

The purpose of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the effectiveness of hormone therapy, with or without an additional investigational medication, in treating breast cancer. Breast cancer is a condition where cells in the breast grow out of control. This study focuses on patients with high-risk breast cancer that is hormone-receptor positive and HER2-negative. Hormone-receptor positive means the cancer cells grow in response to hormones, and HER2-negative indicates that the cancer cells do not have more HER2 proteins than normal.

Participants in this study will be randomly assigned to one of two study arms. One arm will receive standard hormone therapy, while the other arm will receive hormone therapy along with an investigational medication for one year. The study will monitor how well each treatment works in improving invasive disease-free survival, which means living without the cancer spreading to other parts of the body.

  • Who can participate: This study is for patients with high-risk breast cancer that is hormone-receptor positive and HER2-negative. Age criteria not specified.
  • Study details: Participants will receive either standard hormone therapy or hormone therapy with an investigational medication, everolimus, for one year. The investigational medication is being studied for its effectiveness in enhancing treatment outcomes.
Updated on 19 Feb 2024. Study ID: 1309388513 (S1207)

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