A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer

Emory University

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Cancer of the Breast

Breast Neoplasms

Treatments

Drug: Lapatinib and Everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01272141

IRB00031112

WCI1711-09 (Other Identifier)

Details and patient eligibility

About

The patient is being asked to join this clinical research study to find out if lapatinib, an agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface of cancer cells in combination with everolimus, an agent that targets a protein in the cancer cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative breast cancers that are no longer controlled by standard chemotherapy.

Enrollment

5 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed ER(-), PR(-), HER2(-) locally advanced or metastatic breast cancer
Disease progression following prior first line cytotoxic chemotherapy in metastatic setting
At least 1 lesion measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Age >18 years old
Female
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Left ventricular ejection fraction (LVEF) > 50%
Absolute neutrophil count (ANC)>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL; serum creatinine < 1.5x upper limit of normal (ULN); total bilirubin < 1.5x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN
Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion criteria

Patients with current active hepatic or biliary disease (except for patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Patients with an active infection or with a fever > 101.3 Fahrenheit within 3 days of the first scheduled day of protocol treatment
Patients with active central nervous system (CNS) metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin or cervical intra-epithelial neoplasia with two consecutive normal pap smears 6 months apart
Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received radiotherapy to target lesions within 4 weeks of entry
Patients who are receiving concurrent investigational therapy
Peripheral neuropathy >= Grade 2
Patients who are pregnant or lactating
Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
History of allogeneic transplant
Known HIV or Hepatitis B or C (active, previously treated or both)