Study of Erlotinib and Metformin in Triple Negative Breast Cancer
|ClinicalTrials.gov Identifier: NCT01650506|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Metformin Drug: Erlotinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Erlotinib and Metformin in Triple Negative Breast Cancer|
|Actual Study Start Date :||July 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Erlotinib + Metformin
This is a single arm phase 1 study. All patients will receive erlotinib and 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.
Other Name: Glucophage
Erlotinib dosing will start and remain at 150 mg daily.
Other Name: Tarceva
- The maximum tolerated dose of metformin in combination with a fixed dose of 150 mg erlotinib daily [ Time Frame: Up to 5 weeks ]The highest dose of a treatment that does not cause unacceptable side effects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650506
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Kevin Kalinsky, MD||Columbia University|