Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Breast Cancer

What is the Purpose of this Study?

The purpose of this study is to determine whether the addition of chemotherapy to hormonal therapy and ovarian suppression is more effective than the usual approach of hormonal therapy and ovarian suppression alone for treatment in premenopausal women with early-stage, hormone receptor-positive breast cancer. The study focuses on patients with breast cancer that is hormone receptor positive, HER2-negative, and has a higher risk for cancer returning and who would typically receive chemotherapy for risk reduction. These patients would typically receive hormonal therapy and often chemotherapy after surgery. It has long been thought that the benefit of chemotherapy is due to the impact of ovarian suppression. With the study result, the researchers hope to determine whether chemotherapy may be omitted safely in this population. Ovarian suppression is a form of treatment that stops or lowers the amount of estrogen produced by the ovaries.


Eligibility

  • * A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
  • * The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.
  • * Female patients must be greater than or equal to 18 years of age.
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Where can I participate?

  • CS Cancer Tarzana
  • CS Cancer at Beverly Hills
  • CS Cancer at Cedars-Sinai Medical Center
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
  • Huntington Cancer Center, an Affiliate of Cedars-Sinai Cancer


More about this Clinical Trial

What is the full name of this clinical trial?

NRG-BR009: A Phase III Adjuvant Trial 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 < / equal to 25

Study Details
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Co-Investigators

Alice Chung, Amin Mirhadi, Andrew Horodner, Ani Balmanoukian, Benjamin King, Catherine Dang, David Chan, Dorothy Park, Farin Amersi, Hugo Hool, Jin Sun Bitar, Johnny Chang, Justin Wayne Tiulim, Kjirsten Carlson, Lauren DeStefano, Marc Botnick, Maryliza El-Masry, Michele Burnison, Natasha Banerjee, Niki Patel Tank, Philomena McAndrew, Robert Reznik, Ryan Ponec, Scott Karlan, Stephen Shiao, Swati Sikaria, Syed Jilani, Thomas Lowe, Tiffany Shaw, Tina Wang, Vanessa Dickey

Age Group

Adult

Phase

III

IRB Number

STUDY00003264

ClinicalTrials.gov ID

NCT05879926

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Age Group

Adult

Phase

III

IRB Number

NRG-BR009

ClinicalTrials.gov ID

NCT05879926

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org