Clinical Trials

Title   NRG BR005
Principal Investigator/ Physician   Lynn Dyess, MD
Protocol┬áNo.   BR005
Open Date   05/09/2017
Gender   Both
Cancer Site   Breast
Status   Open
Sponsor   NRG
Contact Email   MCI Clinical Trials
Summary  

Protocol: 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

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.

 

Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03188393?term=NRG+BR005&recrs=a&rank=1

Email Newsletters

Connect With Us