A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
The main aim of this clinical trial is to test the effects (good or bad) of a new investigational anticancer drug, PM01183, has on breast cancer. The knowledge obtained from this trial might allow fighting against this type of cancer in a more specific way in the future. PM01183 is a novel anticancer compound that has been selected for further clinical development because of the anti-cancer activity shown in the laboratory and of its adequate toxicity profile in animals.
- drug : PM01183
Phase: Phase 2
Ages Eligible For Study:
- Women ? 18 and ? 75 years of age. - Voluntary signed informed consent form (ICF). - Proven diagnosis of metastatic breast cancer (MBC). - At least one, but no more than three, prior chemotherapy regimens for MBC. - Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease. - Disease evaluable for response by specific appropriate criteria. - No or minimal disease-related symptoms not affecting patient daily activities. - Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function) - Wash out periods prior to Day 1 of Cycle 1: At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy - Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling. - Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration. Inclusion criteria - Specifically to be included in Cohort A (otherwise patients might be included in Cohort B): Known deleterious germline mutation of BRCA1/2 (hereditary breast cancer).