Study of Erlotinib and Metformin in Triple Negative Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Breast Cancer
Interventions
DRUG

Metformin

Due to frequent GI upset in patients starting metformin the dose will be titrated up to the assigned dose level. The first metformin dose level will be 850 mg twice daily and be escalated to its maximum FDA approved dose of 850 mg three times daily. Dose escalation will follow the standard 3 + 3 design. Dose limiting toxicities will be determined during the first 5 weeks of therapy.

DRUG

Erlotinib

Erlotinib dosing will start and remain at 150 mg daily.

Trial Locations (1)

10032

Columbia University, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Susan G. Komen Breast Cancer Foundation

OTHER

collaborator

Astellas Pharma Inc

INDUSTRY

lead

Columbia University

OTHER

NCT01650506 - Study of Erlotinib and Metformin in Triple Negative Breast Cancer | Biotech Hunter | Biotech Hunter