NSABP Biospecimen Discovery Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01850628
Recruitment Status : Recruiting
First Posted : May 9, 2013
Last Update Posted : September 2, 2016
Breast Cancer Research Foundation
Washington University School of Medicine
Information provided by (Responsible Party):
NSABP Foundation Inc

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 paired tumor-normal exome DNA and RNA sequencing.

Condition or disease Intervention/treatment
Breast Cancer Drug: Paclitaxel Biological: trastuzumab Biological: pertuzumab

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NSABP Biospecimen Discovery Project
Study Start Date : July 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Paclitaxel plus trastuzumab or trastuzumab/pertuzumab
Patient received paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination administered per investigators discretion
Drug: Paclitaxel Biological: trastuzumab
Other Name: Herceptin
Biological: pertuzumab

Primary Outcome Measures :
  1. 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 [ 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. ]

Biospecimen Retention:   Samples With DNA
fresh tumor tissue and blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with locally advanced, HER2-positive breast cancer from selected sites in the United States

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01850628

Contact: Diana Gosik, RN, BS 412-339-5333

United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Carmen Allegra, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Principal Investigator: Adel Tabchy, MD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: Thomas Julian, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Mothaffar Rimawi, MD         
Sponsors and Collaborators
NSABP Foundation Inc
Breast Cancer Research Foundation
Washington University School of Medicine
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc

Responsible Party: NSABP Foundation Inc Identifier: NCT01850628     History of Changes
Other Study ID Numbers: NSABP DP-1
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: July 2016

Keywords provided by NSABP Foundation Inc:
National Surgical Adjuvant Breast and Bowel Project (NSABP)
HER2 positive (human epidermal growth factor receptor 2)
Neoadjuvant Therapy
Anthracycline therapy
Locally advanced

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action