Overview

ATI-450 in Combination With Paclitaxel or Capecitabine in Patients With Hormone Receptor-positive and HER2 Negative Metastatic Breast Cancer With Bone Metastasis

Status:
Not yet recruiting

Trial end date:
2028-04-30

Target enrollment:

Participant gender:

Summary

This is a dose-escalating phase I using a rolling 6 design and randomized phase II study of ATI-450 in combination with chemotherapy testing the hypothesis that the combination of chemotherapy (paclitaxel or capecitabine) and ATI-450 will improve progression-free survival and reduce bone turnover, improve patient bone density, improve patient quality of life, and improve clinical efficacy.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Washington University School of Medicine

Collaborators:

Aclaris Therapeutics, Inc.
United States Department of Defense

Treatments:

Bone Density Conservation Agents
Capecitabine
Paclitaxel