Chemotherapy with Hormone Therapy for Breast Cancer

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

Recruiting Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 60
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
3,960 (estimated)
Sponsor
NRG Oncology · Other
Who this trial is looking for

This trial is looking for premenopausal women with early-stage breast cancer that is hormone receptor-positive. Participants will receive hormone therapy and may also get chemotherapy to see if it helps them live longer without cancer returning.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 18 or older.
  • I have been diagnosed with early-stage breast cancer.
  • I have a specific gene test score between 16-25.
  • I have functioning ovaries.
  • I have not had cancer spread to other parts of my body.
  • I have had surgery for my breast cancer within the last 16 weeks.
  • I have a good performance status overall.

You may not be able to join if

  • I have metastatic breast cancer.
  • I have had another invasive breast cancer in the past.
  • I have tumors that are classified as pT4.
  • I have a life expectancy of less than 10 years due to other health issues.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 p…
Contacts

Director Regulatory Affairs

412-339-5300

langerj@nrgoncology.org

CONTACT

Norman Wolmark, MD

CONTACT