NSABP Biospecimen Discovery Project
Information source: NSABP Foundation Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Paclitaxel (Drug); trastuzumab (Biological); pertuzumab (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: NSABP Foundation Inc Official(s) and/or principal investigator(s): Norman Wolmark, MD, Principal Investigator, Affiliation: NSABP Foundation Inc
Overall contact: Diana Gosik, RN, BS, Phone: 412-339-5333, Email: diana.gosik@nsabp.org
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.
Clinical Details
Official title: NSABP Biospecimen Discovery Project
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Diana Gosik, RN, BS, Phone: 412-339-5333, Email: diana.gosik@nsabp.org
University of Florida, Gainesville, Florida 32610, United States; Recruiting Carmen Allegra, MD, Principal Investigator
Henry Ford Hopital, Detroit, Michigan 48202, United States; Recruiting Thomas J Doyle, MD, Principal Investigator
Washington University School of Medicine, St Louis, Missouri 63110, United States; Recruiting Adel Tabchy, MD, Principal Investigator
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting Thomas Julian, MD, Principal Investigator
Magee-Women's Hospital of UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting Adam Brufsky, MD, Principal Investigator
Additional Information
Starting date: July 2013
Last updated: June 24, 2015
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