Page 11 - Delaware Medical Journal - March 2018

CANCER CLINICAL TRIAL
PROTOCOL OF THE MONTH
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
Primary Objective:
•To assess 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 (von Minckwitz 2012), 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).
Secondary Objectives:
•To collect axillary pathology results, surgical staging methods (sentinel lymph node biopsy and/or axillary lymph node dissection), and management (surgery and/or radiation) in order to determine axillary nodal response to neoadjuvant chemotherapy and its relationship to breast pCR. In addition, to correlate imaging results with pathologic nodal status following neoadjuvant chemotherapy for future planning of axillary management in the next study.
•To retrospectively assess the negative predictive value (NPV) of a trimodality imaging algorithm in combination with the tumor bed biopsy for predicting pCR, and to collect all trimodality imaging data to determine which combination of the trimodality imaging best identifies the group achieving pCR.
•To correlate the number of needle cores and tumor bed clip retrieval with the NPV of the tumor site biopsy.
•To determine the clinical, imaging, pathologic, and molecular tumor factors associated with the highest NPVs of post-NST tumor bed biopsies.
•To improve identification and selection of patients with breast and possible axillary pCR for future trial planning, routine biomarkers (ER, PR, HER2 neu, and Ki67) will be collected to allow comparison to image/clinical CR, and tumor bed biopsies.
Eligibility Criteria:
•Male or female ≥18 years of age, ECOG Performance status of 0 or 1, and ER, PR and HER2 testing must be done.
•Must have a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or MRI is acceptable) of marker placement prior to neoadjuvant chemotherapy.
•Patients with operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination).
•Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI.
•Patients must be undergoing breast conserving therapy.
•Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy.
•Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
•Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
•Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible. •Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible.
Treatment:
Biopsy
Neoadjuvant: Doctor choice
Assess Response by Trimodality Imaging THEN Register to study Image Guided CORE Biopsy
Surgery
For information regarding clinical trials or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | March 2018 | Vol. 90 | No. 3 75