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

NCT03128619 PHASE1 TERMINATED

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.

Details

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	PHASE1
Status	TERMINATED
Enrolment	10
Start date	Wed Aug 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Mar 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Estrogen Receptor Positive
• HER2/Neu Negative
• Invasive Breast Carcinoma
• Multifocal Breast Carcinoma
• Postmenopausal
• Progesterone Receptor Positive
• Stage I Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer

Interventions

• Biopsy of Breast
• Copanlisib
• Laboratory Biomarker Analysis
• Letrozole
• Palbociclib
• Pharmacological Study

Countries

United States