BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Capecitabine; Docetaxel; Epirubicin

Criteria

Inclusion Criteria:

• Histological diagnosis of breast cancer

• Inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy

• Age < 70 years

• ECOG performance status < 2

• Written informed consent

Exclusion Criteria:

• Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)

• Previous treatment with docetaxel

• Symptomatic brain metastases

• Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl

• Creatinine > 1.25 x the upper normal limits

• GOT and/or GPT > 1.25 x the upper normal limits in absence of hepatic metastases

• GOT and/or GPT > 2.5 x the upper normal limits in presence of hepatic metastases

• Bilirubin > 1.5 x the upper normal limit

• Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study

• Inability to provide informed consent

• Inability to comply with follow-up