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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

Page last updated: August 23, 2015

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