Study of Erlotinib and Metformin in Triple Negative Breast Cancer (NCT01650506) | Clinical Trial Compass
CompletedPhase 1
Study of Erlotinib and Metformin in Triple Negative Breast Cancer
United States8 participantsStarted 2012-07
Plain-language summary
Extended phase 1 trial of combined metformin and erlotinib in advanced triple negative breast cancer patients. The goals of the study are to establish the maximum tolerated combined dosing of erlotinib and metformin as well as deciding if there is a potential clinical utility of the combination in treating patients with triple negative breast cancer.
Who can participate
Age range18 Years – 79 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed pathologic diagnosis of triple negative breast cancer, OR Prior diagnosis of ER or P-R positive breast cancer \[HER2 negative\] that is demonstrated to be both ER and P-R negative (no or rare staining) on the patient's most recent biopsy.
* Patients with measurable or non-measurable metastatic disease (RECIST 1.1).
* At least one prior treatment for metastatic disease.
* Availability of adequate tumor tissue for exploratory analysis and plan to obtain the material.
* Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. No chemotherapy or radiotherapy may be given within 2 weeks prior to the start of protocol treatment.
* Patients must be ≥ 18 and \< 80 years old.
* Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2.
* Life expectancy of greater than 12 weeks.
* Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
* Required Laboratory Values: Absolute neutrophil count (ANC) ≥1,250/mm3, platelets ≥75,000/mm3, hemoglobin ≥8.5 g/dL, total bilirubin ≤1.5 x ULN, Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) ≤3.0 x ULN, alkaline phosphatase ≤2.5 x ULN, Patients must have either a normal serum creatinine (\<= IULN) OR estimated creatinine clearance ≥ 60 ml/min (Cockcro…
What they're measuring
1
The maximum tolerated dose of metformin in combination with a fixed dose of 150 mg erlotinib daily