Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 23, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
Interventions
DRUG

Letrozole

A dose of 2.5 mg of letrozole will be given orally once each day until one day before surgery. This drug is commercially available and is not provided by the study.

DRUG

Everolimus

The dose of everolimus will be escalated from 5 mg to 10 mg daily depending upon the cohort in Phase I. It is administered as an oral pill to be taken once daily up until four weeks prior to surgery.

DRUG

TRC105

The dose for TRC105 is either 15 or 10 mg/kg to be given intravenously every two weeks and continued until four weeks prior to surgery.

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Tracon Pharmaceuticals Inc.

INDUSTRY

lead

University of Alabama at Birmingham

OTHER