NSABP Biospecimen Discovery Project

Breast Cancer Clinical Trial

Official title:

NSABP Biospecimen Discovery Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01850628
• Other study ID #: NSABP DP-1
• Status: Active, not recruiting
• Start date: July 2013
• Est. completion date: February 2022

Study information

• Verified date: October 2021
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2022
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Paclitaxel

Biological:
• trastuzumab

• pertuzumab

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	New York University School of Medicine	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
NSABP Foundation Inc	Breast Cancer Research Foundation, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.