Trial record 4 of 9 for:    DP-1

NSABP Biospecimen Discovery Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Surgical Adjuvant Breast and Bowel Project (NSABP)
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT01850628
First received: May 1, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 Intervention
Breast Cancer
Drug: Paclitaxel
Biological: trastuzumab
Biological: pertuzumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NSABP Biospecimen Discovery Project

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

fresh tumor tissue and blood samples


Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders 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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850628

Contacts
Contact: Diana Gosik, RN, BS 412-339-5333 diana.gosik@nsabp.org

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Carmen Allegra, MD         
United States, Michigan
Henry Ford Hopital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Thomas J Doyle, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Principal Investigator: Adel Tabchy, MD         
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: Thomas Julian, MD         
Magee-Women's Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Adam Brufsky, MD         
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Breast Cancer Research Foundation
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  More Information

No publications provided

Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT01850628     History of Changes
Other Study ID Numbers: NSABP DP-1
Study First Received: May 1, 2013
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
paclitaxel
trastuzumab
pertuzumab
HER2 positive (human epidermal growth factor receptor 2)
Proteomics
Neoadjuvant Therapy
Anthracycline therapy
Locally advanced
Operable
Biomarkers

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014