Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic ResponseStatus: 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
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.
SponsorsThis trial is sponsored by NRG.
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Providers Associated With This Trial
- Donna Lynn Dyess, M.D.Breast/Endocrine SurgeonProfessor of Surgery
- Daniel G. Cameron, M.D.Medical OncologistSenior Staff Medical Oncologist, Medical Oncology Service; Associate Professor of Interdisciplinary Clinical Oncology
- Elesyia D. Outlaw, M.D.Radiation OncologistDirector of Women's Radiotherapy Program; Program Director of Brachytherapy Program; Associate Professor of Interdisciplinary Clinical Oncology