Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer

This study is a single-arm, open-label, phase 2 study of a regimen of dose-dense pemetrexed and sorafenib to determine the objective response rate in patients with recurrent or metastatic TNBC. Eligible patients will be those who have had disease progression during or after treatment for recurrent or metastatic disease with one previous cytotoxic chemotherapy regimen. Additionally, patients with disease progression or recurrence during or within 6 months of completion of adjuvant or neoadjuvant therapy are also eligible. Correlative studies will be conducted using blood samples and archived tumor samples.

Simon's two-stage design will be utilized in this study. In the first stage, if there are ≤ 3 patients of the first 18 efficacy-evaluable patients who have a partial or complete response, then the trial will end for futility. If ≥ 4 patients have a partial or complete response, patient accrual will continue in the second stage to add 10 more efficacy-evaluable patients.

The total sample size for the Simon's two-stage design is 35 patients. Based on enrollment of 2-3 patients per month, the expected enrollment period will be about 12-18 months.

Patients were enrolled in 2 sequential groups, referred to as "arms" for the purposes of reporting results by group. The initial group of patients were enrolled in what is referred to here as Arm A. After a study amendment patients were enrolled in what is referred to here as Arm B.