Status:
UNKNOWN
NSABP Biospecimen Discovery Project
Lead Sponsor:
NSABP Foundation Inc
Collaborating Sponsors:
Breast Cancer Research Foundation
Washington University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 p...
Detailed Description
This study will be conducted at select NSABP sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadju...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01850628
Start Date
July 1 2013
End Date
February 1 2022
Last Update
October 5 2021
Active Locations (5)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
New York University School of Medicine
New York, New York, United States, 10016
4
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212