Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

Trial Information

Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

This is an open-label, clinical trial evaluating the effectiveness and safety of trabectedin
in three subpopulations of breast cancer patients: Group A: triple negative profile (ER-,
PR-, HER-2-), Group B: human epidermal growth factor receptor-2 overexpressing tumors
(HER-2+) and Group C: familial BRCA1 or BRCA2 mutation carrier. Each subtype is defined
according to the estrogen, progesterone, and the Human Epidermal Growth Factor Receptor- 2
(HER-2) status in the primary tumor (present or overexpressing = positive or absent or do
not overexpressing = negative) or the history of having BRCA1 or BRCA2 mutation genes.
Trabectedin will be administered intravenously (iv) every three weeks. Patients will be
assessed weekly physical exam and / or laboratory testing. Radiological examination will
occur every 6 weeks to evaluate the patient's disease. Treatment will continue as long as
the patient tolerating trabectedin and their disease is stable or improving. Duration of
response, progression free-survival, exploratory evaluation of changes in tumor volume and
changes in tumoral radiological density, safety profile and exploratory,
hypothesis-generating pharmacoecogenomic analyses will be assessed.Patients are evaluable
for safety if they received at least part of one infusion of trabectedin. Safety will be
assessed by adverse events, laboratory measurements, and clinical examinations Trabectedin
will be administered intravenously (iv) at a dose of 1.3 mg/m2 over 3-hours (hrs) on Day 1
of every 21-day treatment cycle. In addition, patients will be administered dexamethasone on
Day 1 of each treatment cycle as follows: 4mg orally (PO) 24h and 12h before the trabectedin
iv infusion, 20 mg, iv 30 minutes before the trabectedin infusion, and 4 mg PO 24h, 36h,
48h, 60h, 72h, after the start of trabectedin infusion.