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Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25

Testing chemo with hormone therapy in certain premenopausal breast cancer patients.

Recruiting
18-60 years
Female
Phase 3

This study is for young women with early-stage breast cancer. The study checks if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) and endocrine therapy (ET) helps them live longer without cancer returning. OFS stops the ovaries from making estrogen, a hormone that can help cancer grow. The study is for women who haven’t reached menopause and have specific types of breast cancer that are estrogen receptor (ER)-positive and HER2-negative. Eligible participants need a 21-gene recurrence score (Oncotype DX RS) of 25 or less. This score helps predict cancer's return risk. Participants must be 18 or older and still have functioning ovaries.

  • Study participation may include multiple visits and treatments.
  • There may be risks, like chemotherapy side effects.
  • Benefits could include better survival rates and compensation may be available.

Before joining, participants must understand the study and agree to share health info. They must meet specific health criteria and can’t have certain other health issues. This study aims to find better treatment options for young breast cancer patients.

Study details
    Breast Cancer

NCT05879926

NRG Oncology

8 March 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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