Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer

Breast Cancer Clinical Trial

Official title: An Umbrella, Randomized, Controlled, Pre Operative Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.

Clinical Trial Description

Primary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy in in reducing Ki67 values based on digital pathology (QuPath) from baseline to on-treatment biopsy after an specific treatment duration (i.e. 14 days) in ER-positive, HER2-negative tumors (tumor size ≥1 cm) with Ki67 ≥ 10%, for different integrative subtype categories identified at integrative subtype screening.

Secondary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy on the proportion of subjects with Ki67 < 10% after a specific treatment duration (i.e. 14 days) ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• ER Positive Breast Cancer
• HER2-negative Breast Cancer

• NCT number: NCT05101564
• Study type: Interventional
• Source: Stanford University
• Contact: Allison Zhang
• Phone: 650-736-5790
• Email: axkong@stanford.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2023
• Completion date: December 2026