drugset / Trial / NCT03128619

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

NCT03128619

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole, and palbociclib may work better in treating patients with breast cancer.

Timeline

Start
2017-08-02
Primary completion
2022-03-31
Completion
2022-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Copanlisib Small molecule Intravenous
Subject Letrozole Other / unclassified Oral
Subject Palbociclib Small molecule Oral