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

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.

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
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage III Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

PROCEDURE

Biopsy of Breast

Undergo biopsy

DRUG

Copanlisib

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Letrozole

Given PO

DRUG

Palbociclib

Given PO

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

• Bayer

  collaborator INDUSTRY

• Translational Research in Oncology-U.S. Inc. (TRIO-US)

  collaborator UNKNOWN

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Sara Hurvitz · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-02

Primary Completion

2022-03-31

Completion

2022-03-31

FDA Drug

Yes

Countries

• United States

Study Locations