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Adjuvant Chemotherapy with Ovarian Function Suppression Plus Endocrine Therapy in Patients With pN0-1, ER-Positive/​HER2-Negative Breast Cancer

Short Title: NRG-BR009/OFSET


Enrollment Status: Recruiting

NCT #: NCT05879926

Specialty Area: Oncology

Condition Studied: Early Stage Breast Cancer

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To find out if adding chemotherapy to ovarian function suppression and endocrine therapy helps prevent breast cancer from coming back in premenopausal patients with ER+/HER2− tumors and a low to intermediate Oncotype Recurrence Score.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with estrogen receptor-positive (ER+) and HER2-negative early-stage breast cancer
  • Premenopausal
  • Must have a 21-gene Oncotype Recurrence Score (ORS) between 16–25 (for patients with no lymph node involvement) or 0–25 (for patients with limited lymph node involvement)

What's Involved

Participation in the study will include:
  • Ovarian function suppression plus endocrine therapy, with or without adjuvant chemotherapy
  • Monitoring for recurrence-free interval over time
  • Blood and urine tests to monitor your health and treatment effects
  • Electrocardiogram (ECG) to monitor heart function
  • Questionnaires

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT05879926

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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