NCT01850628

NSABP Biospecimen Discovery Project

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: NSABP Foundation Inc · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel
BIOLOGICAL	trastuzumab
BIOLOGICAL	pertuzumab

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-06-01
• Completion: 2022-02-01
• First posted: 2013-05-09
• Last updated: 2021-10-05

Locations

5 sites across 1 country: United States