Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients

• Status: Completed
• Trial end date: 2010-07-07
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Schering-Plough
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

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.