NSABP Biospecimen Discovery Project

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NSABP Foundation Inc
• Collaborators: Breast Cancer Research Foundation; Washington University School of Medicine
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.

• The breast cancer must be HER2-positive based on current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer.

• The patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. Patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy.

• Planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. Schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator.

Exclusion Criteria:

• Excisional biopsy or lumpectomy performed prior to registration.

• Previous therapy with chemotherapy or targeted therapy for any malignancy.

• Treatment, including radiation therapy (RT), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration.

• Other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy.