Treatment of metastatic breast cancer MedDRA version: 7.0 Level: PT Classification code 10055113
Conditions
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ambulant female patients aged =18 years with histologically or cytologically confirmed metastatic breast cancer who have received prior chemotherapy with an anthracycline and taxane. Patients must have completed all previous treatments (including surgery and radiotherapy) more than 4 weeks prior to treatment start and must have made a full recovery from any acute toxicities. Patients must have at least one uni-dimensionally measurable lesion according to the RECIST criteria, Karnofsky performance status of >70% and have given written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not have received more than two chemotherapy regimens for advanced/metastatic disease or more than three regimens in total (including neo-adjuvant and adjuvant disease settings). Patients will be excluded who have any of the following laboratory parameters: hemoglobin 25 mmol/l (1.5 mg/dl); other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit in the presence of hepatic metastases); serum creatinine >1.5 x ULN; serum calcium (corrected for albumin) >11.5 mg/dl. Patients will be excluded who have progressive CNS metastases, a history of another malignancy within 5 years of study entry, significant cardiac disease, malabsorption syndrome, known hypersensitivities to sulfonamides or previous reactions to fluoropyrimidine therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy, safety and tolerability of indisulam (I) in combination with capecitabine (C) versus capecitabine (C) monotherapy in patients with metastatic breast cancer following prior anthracycline and taxane therapy. The primary objective is to demonstrate superior time to progression with the IC combination regimen.;Secondary Objective: The secondary objectives include: comparison of response rate and duration of response; one-year and median overall survival; pain and analgesia scores; and safety and tolerability. ;Primary end point(s): The primary endpoint is to demonstrate superior time to progression with the IC combination regimen. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed