Study on Adding Chemotherapy to Hormone Therapy for Premenopausal Women with Early-Stage ER-Positive/HER2-Negative Breast Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05879926

Provider View

This Phase III clinical trial is exploring whether adding chemotherapy to hormone therapy and ovarian function suppression can improve outcomes for premenopausal women with early-stage ER-positive/HER2-negative breast cancer and a specific genetic test score.

Patient Parameters

Program Overview

The study aims to find out if adding chemotherapy to ovarian function suppression and hormone therapy is more effective in preventing the return of breast cancer in premenopausal women with early-stage ER-positive/HER2-negative breast cancer. The trial focuses on patients with a 21-gene recurrence score between 16-25 for those with no lymph node involvement and 0-25 for those with some lymph node involvement.

Description

Younger women diagnosed with early-stage breast cancer often face a higher risk of the disease returning compared to older women. This study is looking at whether adding chemotherapy to hormone therapy and ovarian function suppression can help improve outcomes for these women. Ovarian suppression has been used in breast cancer treatment for over a century, but its role alongside chemotherapy has been debated. Previous studies have shown that ovarian suppression can be as effective as chemotherapy, especially in younger women. This trial will help determine if combining these treatments can better prevent cancer recurrence in premenopausal women with specific genetic test scores.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent and allow the release of personal health information.
  • Female and at least 18 years old.
  • Premenopausal status, defined by age and menstrual history or hormone levels.
  • Good overall health with a performance status score of 2 or less.
  • May have certain types of breast cancer if they meet specific criteria.
  • Must have had surgery to remove the breast cancer, with clear margins if a lumpectomy was performed.
  • Must have had axillary staging to check lymph nodes.
  • Must meet specific staging criteria for the tumor and lymph nodes.
  • Must have a specific range of Oncotype DX recurrence scores.
  • Tumor must be ER and/or PgR-positive and HER2-negative.
  • Must start the study within 16 weeks of the last breast cancer surgery.
  • Short-term hormone therapy before the study is allowed.
  • May have had other cancers if they don't interfere with the study.
  • HIV-positive patients on effective treatment are eligible.
  • Radiation therapy should follow standard guidelines.

Exclusion Criteria

  • Evidence of cancer spread beyond the breast.
  • Certain advanced or inflammatory breast cancers.
  • History of invasive breast cancer on the same or opposite side.
  • Life expectancy less than 10 years due to other health conditions.
  • Abnormal blood test results indicating low blood cell counts or poor liver or kidney function.
  • History of heart disease or treatment with heart-damaging drugs.
  • Non-epithelial breast cancers like sarcoma or lymphoma.
  • Previous treatment for the current breast cancer before joining the study.
  • Use of hormonal contraceptives must be stopped before joining.
  • Active hepatitis B or C infections unless under control.
  • Pregnant or breastfeeding women.
  • Any other conditions that might interfere with the study.

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