NRG-BR005

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery

Principal Investigator

Mark Basik

Status

Disease Site

Breast [BR] Breast

Phase

II

Developmental Therapeutics

No

Primary Objective

To access the accuracy of post-neoadjuvant systemic therapy (NST) image-directed tumor bed biopsy for pathologic complete response (pCR), defined as resolution of both invasive disease and DCIS, in cases of clinical and radiologic complete response with trimodality imaging. This will determine whether post-NST tumor bed needle core biopsies in addition to clinical examination and trimodality imaging can identify appropriate patients after NST, who are optimal candidates to proceed with radiotherapy treatment without formal breast conserving surgery (lumpectomy).

Patient Population

Patients with operable focal or multifocal T1-T3, stage II and IIIA invasive ductal carcinoma (all receptor phenotypes) with clinical complete response by physical exam and radiologic complete response by trimodality imaging after neoadjuvant systemic therapy

Target Accrual

175