Conditions: Breast Cancer Ovarian Cancer
Keywords: BRCA defective
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 74
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of 6-mercaptopurine (6MP) in combination with methotrexate (MTX) in patients with breast or ovarian cancer who are known to have a BRCA (breast cancer gene) mutation.

Detailed description:
This study will evaluate the efficacy and safety of 6-mercaptopurine (6MP) in combination with methotrexate (MTX) in patients with breast or ovarian cancer who are known to have a BRCA (breast cancer gene) mutation. 6MP is used instead of thioguanine(6TG) as it is converted to the same cytotoxic moiety as 6TG, ie. thioguanine nucleotides, but with reduced toxic effects. Low dose methotrexate is used in combination with 6MP as it promotes the formation of thioguanine nucleotides.

Arms:
arm 1: 6-Mercaptopurine 55mg/m2 per day, and methotrexate 15mg/m2 per week

Interventions: intervention 1: 6-Mercaptopurine intervention 2: Methotrexate
Intervention descriptions: intervention 1: 6-Mercaptopurine (6MP) 55mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression. intervention 2: Methotrexate (MTX) 15 mg/m2 taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.

Protocol document: