Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response

Status: open

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

Treatment for Breast Cancer

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Description

Inclusion Criteria: (ECOG) performance status of 0 or 1; must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy; must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy; must have a biopsy marker placed within the tumor bed with imaging confirmation; Patients with operable focal or multifocal and who have completed neoadjuvant chemotherapy with a clinical complete response; achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI; must be undergoing breast conserving therapy. Exclusion Criteria:T4 tumors including inflammatory breast cancer; metastatic disease; Lumpectomy performed prior to study entry; history of prior radiation therapy in the affected breast; synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer; invasive lobular carcinoma; have multicentric disease; treated with neoadjuvant hormonal therapy only; atients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy.

Sponsors

This trial is sponsored by NRG.

Providers Associated With This Trial

Principle Investigator

Sub Investigators

  • Daniel CameronView Profile
    Daniel G. Cameron, M.D.Medical OncologistSenior Staff Medical Oncologist, Medical Oncology Service; Associate Professor of Interdisciplinary Clinical Oncology
  • Elesyia OutlawView Profile
    Elesyia D. Outlaw, M.D.Radiation OncologistDirector of Women's Radiotherapy Program; Program Director of Brachytherapy Program; Associate Professor of Interdisciplinary Clinical Oncology
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