Clinical Trials

Title   Alliance A011202
Principal Investigator/ Physician   Lynn Dyess, MD
Protocol┬áNo.   A011202
Open Date   09/08/2015
Gender   Both
Cancer Site   Breast
Status   Open
Sponsor   Alliance for Clinical Trials in Oncology
Contact Email   MCI Clinical Trials

Protocol Tiltle:  "A randomized phase III trial comparing axillary lymph node dissection to axillary radiation in breast cancer patients (cT1-3N1) who have positive sentinel lymph node disease after neoadjuvant chemotherapy."

Inclusion Criteria:  ECOG status 0-1. Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition. No inflammatory breast cancer. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix. All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy. Patients must have had estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry [IHC] and/or fluorescence in situ hybridization [FISH] evaluated on diagnostic core biopsy. Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Patients must have completed at least 6 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes.

Exclusion Criteria: Neoadjuvant endocrine or radiation therapy. Sentinel lymph node (SLN) surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy. Prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.

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