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

Nancy Knowles Cancer Center - Elmhurst

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 (for pN0 patients) and 0-25 (for pN1 patients).

Sponsor: NRG Oncology

https://clinicaltrials.gov/ct2/show/record/NCT05879926

Inclusion Criteria includes:

• Female patients must be greater than or equal to 18 years of age.
• Patients must be premenopausal.
• 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.
• Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
• For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be free of invasive tumor and DCIS.
• For patients who undergo mastectomy, the margins must be free of residual gross tumor.
• The tumor must be ER and/or PgR-positive (greater than or equal to 1% ER and/or PgR).
• The tumor must be HER2-negative.
• The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.
• Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.

Exclusion Criteria includes:

• Definitive clinical or radiologic evidence of metastatic disease.
• History of ipsilateral or contralateral invasive breast cancer.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents. To be eligible for this trial, patients should be class 2B or better.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.

Approx. 15 years