Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients

GEICAM 2001-01

This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.

2002-10-28

2007-06-01

2010-07-07

Completed

Early phase I

288

Inclusion Criteria: * Written informed consent. * Patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment. * Age: at least 18 years old. * Performance status Eastern Cooperative Oncology Group (ECOG) scale 0, 1, 2. * Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF). * Hematology: leucocytes \>= 4 x 10\^9/l; neutrophils \>= 2.0 x 10\^9/l; platelets \>= 100 x 10\^9/l; hemoglobin \<= 10 g/dl. * Hepatic function: total bilirubin \< 1 upper limit of normal (UNL); aspartate aminotransferase (ASAT) (SGOT) and alanine aminotransferase (ALAT) (SGPT) \< 2.5 UNL; alkaline phosphatase \< 5 UNL. Patients with ASAT (SGOT) and ALAT (SGPT) \> 1.5 UNL and alkaline phosphatase \> 2.5 UNL are not eligible. * Renal function: creatinine \< 175 mmol/l (2 mg/dl); creatinine clearance \> 45 ml/min. Exclusion Criteria: * Pregnant or lactating patients. * Previous cardiac dysfunction grade II or higher as per New York Heart Association, along with congestive cardiac failure. * Hypersensitivity to anthracyclines or Cremophor®. * Clinically significant hepatic dysfunction. * Current uncontrolled infection. * Mental confusion and lack of orientation. * Any circumstance precluding an adequate follow-up. * Radiotherapy in the previous 4 weeks. * Any other concurrent neoplasm, except for basal cell carcinoma or in situ carcinoma. * Symptomatic metastasis in the brain. * Previous radiotherapy radiating a third of haematopoietic centres. * Males.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 288, 'type': 'ACTUAL'}}

2023-03-06