Study of Erlotinib and Metformin in Triple Negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT01650506 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : August 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Metformin Drug: Erlotinib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Erlotinib + Metformin
This is a single arm phase 1 study. All patients will receive erlotinib and metformin.
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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.
Other Name: Glucophage Drug: Erlotinib 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.

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 (Cockcroft-Gault formula) within 14 days prior to registration.
- Concomitant Medications: Erlotinib is primarily metabolized by CYP3A4. Patients CANNOT be receiving enzyme-inducing or enzyme inhibiting agents listed here: Inhibitors: Amiodarone, Amprenavir, Atazanavir, Chloramphenicol, Clarithromycin, Conivaptan, Cyclosporine, Darunavir, Dasatinib, Delavirdine, Diltiazem, Erythromycin, Fluconazole, Fluoxetine, Fluvoxamine, Fosamprenavir, Imatinib, Indinavir, Isoniazid, Itraconazole, Ketoconazole, Lapatinib, Miconazole, Nefazodone, Nelfinavir, Posaconazole, Ritonavir, Quinupristin, Saquinavir, Tamoxifen, Telithromycin, Troleandomycin, Verapamil, Voriconazole. Inducers: Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Efavirenz, Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John's wort, Sulfadimidine, Sulfinpyrazone, Troglitazone, Troleandomycin. All concomitant medications must be recorded.
- Sexually Active Patients: For all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation. The non-pregnant status will be determined in all women of childbearing potential.
- Patients must have signed an approved informed consent.
Exclusion Criteria:
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Active central nervous system (CNS) disease
a. Subjects with a history of CNS metastases or cord compression are allowable if they have been clinically stable for at least 6 weeks since completion of definitive treatment, are off steroids (if the steroids were part of the CNS disease treatment), and in the case of brain metastases, have stable or improved imaging at least 6 weeks after completion of their definitive treatment.
- Any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
- Patients pregnant or nursing.
- Patients who have used tobacco or nicotine products or medications within the last three months given their significant effect on erlotinib drug levels.
- Diabetes. Defined as HgbA1C ≥ 6.5%.
- Prior metformin treatment OR EGFR targeted therapy.
- Rapidly progressive disease as judged by the investigator (Examples include rapidly deteriorating performance status or symptomatic lymphangitic spread).
- Patient has any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association (NYHA) Class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650506
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 |
Principal Investigator: | Kevin Kalinsky, MD | Columbia University |
Responsible Party: | Kevin Kalinsky, Assistant Professor of Medicine, Columbia University |
ClinicalTrials.gov Identifier: | NCT01650506 |
Other Study ID Numbers: |
AAAF3743 |
First Posted: | July 26, 2012 Key Record Dates |
Last Update Posted: | August 30, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Triple Negative Basal-like |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Metformin |
Erlotinib Hydrochloride Hypoglycemic Agents Physiological Effects of Drugs Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |