NCT03939897 - Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 17, 2020

Primary Completion Date

June 22, 2023

Study Completion Date

August 14, 2026

Conditions

Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast CarcinomaRecurrent Breast Carcinoma

Interventions

DRUG

Abemaciclib

Given PO

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Copanlisib Hydrochloride

Given IV

PROCEDURE

Diagnostic Imaging Testing

Undergo imaging

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fulvestrant

Given IM

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

Trial Locations (14)

10016

Bellevue Hospital Center, New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

27012

Wake Forest University at Clemmons, Clemmons

27157

Wake Forest University Health Sciences, Winston-Salem

35233

University of Alabama at Birmingham Cancer Center, Birmingham

40536

University of Kentucky/Markey Cancer Center, Lexington

43210

Ohio State University Comprehensive Cancer Center, Columbus

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63136

Siteman Cancer Center at Christian Hospital, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

92627

UC Irvine Health Cancer Center-Newport, Costa Mesa

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

All Listed Sponsors

lead

National Cancer Institute (NCI)

NIH