This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
• The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information.
The patient must have an ECOG performance status of 0 or 1.
The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision 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. (Patients with margins positive for LCIS are eligible without additional resection.)
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
• Definitive clinical or radiologic evidence of metastatic disease.
pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
Patient had a mastectomy.
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator