NSABP Biospecimen Discovery Project
18 Years
N/A
Female
Breast Cancer
Trial Information
NSABP Biospecimen Discovery Project
This study will be conducted at select NSABP sites where investigators are willing to give
paclitaxel plus trastuzumab before the anthracycline-based component of neoadjuvant therapy
as a pilot for a comprehensive 'omics approach using next generation sequencing and protein
expression and post-translational modification analysis using mass spectrometry (MS) based
and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at
baseline and 48 to 72 hours after initial drug treatment to study variation in the
biological responses to these agents. The study of tumors both before and early after the
first treatment probes the biological responses to treatment and is rich source of
predictive biomarkers.
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. Schedule
for paclitaxel/trastuzumab 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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab
Outcome Time Frame:
blood and tissue specimens will be collected at the time of diagnosis; prior to treatment; 48 and 72 hours following first dose of treatment; and following surgery, if tumor remains.
Safety Issue:
No
Principal Investigator
Norman Wolmark, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NSABP Foundation, Inc.
Authority:
United States: Institutional Review Board
Study ID:
NSABP DP-1
NCT ID:
NCT01850628
Start Date:
June 2013
Completion Date:
March 2015
Related Keywords:
- Breast Cancer
- National Surgical Adjuvant Breast and Bowel Project (NSABP)
- paclitaxel
- trastuzumab
- HER2 positive (human epidermal growth factor receptor 2)
- Proteomics
- Neoadjuvant Therapy
- Anthracycline therapy
- Locally advanced
- Operable
- Biomarkers
- Breast Neoplasms
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