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
Clinical Trial Information
Trial Contact: Caparas, Maria-Lourdes; Rompola, Melissa
IRB No: NRG BR005
Protocol Abbrev: NRG BR005
Principal Investigator: Terry P. Mamounas, MD
Sub Investigators: Cuesta, Ana MD; Baidas, Said MD; Moroose, Rebecca MD; Rostorfer, Regan MD; Shah, Nikita MD
Age Group: Adult
Secondary Protocol No: BR005
Applicable Disease Sites: Breast Cancer
ClinicalTrials.gov ID: NCT03188393
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 in cases of clinical and radiologic complete response with trimodality imaging.
The trial is open to female and male patients.
Age ≥ 18 years.
The patient must have an ECOG Performance status of 0 or 1
Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing
Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer (http://www.asco.org). Patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible.
Patients 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
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.