NSABP Biospecimen Discovery Project

Sponsor

NSABP Foundation Inc (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01850628

Collaborator

Breast Cancer Research Foundation (Other), Washington University School of Medicine (Other)

Enrollment

Locations

103.1

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NSABP Biospecimen Discovery Project

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	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 Names: Herceptin Biological: pertuzumab

Arm

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 Names:

Herceptin

Biological: pertuzumab

Outcome Measures

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 [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
3	New York University School of Medicine	New York	New York	United States	10016
4	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
5	Baylor College of Medicine	Houston	Texas	United States	77030