Breast Cancer Clinical Trial
Official title:
Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer
The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.
This is an open label, multi-center, Phase 2 study of pralatrexate with vitamin B12 and folic
acid supplementation in patients with advanced or metastatic breast cancer who have failed
prior treatment(s).
The start of study treatment is defined as the initiation of pralatrexate administration.
Pralatrexate will be administered as an intravenous (IV) push over 3-5 minutes on days 1 and
15 (± 1 day at each time point) of a 4-week cycle (ie, every [q] 2 weeks). The initial dose
of pralatrexate will be 190 mg/m2. Dose reduction to 150 mg/m2 with further reduction to 120
mg/m2 and 100 mg/m2 will be allowed for defined toxicity (see Section 7.3). If 100 mg/m2 is
not tolerated, pralatrexate must be discontinued.
Patients will receive vitamin supplementation consisting of vitamin B12, 1 mg intramuscular
(IM) q 8-10 weeks and folic acid 1-1.25 mg by mouth (PO) once a day (QD). Patients must have
received 1 mg vitamin B12 within 10 weeks prior to the initiation of pralatrexate and have
received 7 days of 1-1.25 mg folic acid PO QD prior to the initiation of pralatrexate.
Vitamin supplementation will continue throughout the study and for at least 30 days after the
last administration of pralatrexate.
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