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/HER-2 Negative Breast Cancer and an Oncotype Recurrence Score < 25

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Protocol: NRG-BR009

SCHEMA NRG-BR009

Please Note: Below is a brief description of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss the full eligibility requirements.

Eligibility:

1. Female patients must be ≥ 18 years of age.
2. Patients must be premenopausal (evidence of functioning ovaries) at the time of preentry.
3. The patient must have an ECOG performance status of ≤ 2 (or Karnofsky ≥ 60%).
4. Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
5. Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
6. Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
7. For patients who undergo a lumpectomy, the margins of the resected specimen or reexcision must be histologically free of invasive tumor and DCIS with no ink on tumor as
   determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive
   posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS are eligible without additional resection.).
8. For patients who undergo mastectomy, the margins must be free of residual gross tumor.
9. Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).
10. Oncotype DX RS requirements: If node-negative: Oncotype DX RS must be RS 21-25, or Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size > 3 cm, intermediate histologic grade with primary tumor size > 2 cm, or high histologic grade with primary tumor size > 1 cm. If 1-3 nodes involved: Oncotype DX RS must be < 26. Patients with a “Low Risk” or “MP1” MammaPrint result must have eligibility assessed with an Oncotype DX RS at pre-entry.
11. The tumor must be ER and/or PgR-positive. Patients with ≥ 1% ER and/or PgR staining by IHC will be classified as positive.
12. The tumor must be HER2-negative.
13. Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy.
14. Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.