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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: docetaxel; Drug: epirubicin; Drug: capecitabine

• Registration Number: NCT00540800
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Detailed Description

Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin.

Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine.

All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	epirubicin	Weekly chemotherapy
A	epirubicin	Three-weekly chemotherapy
A	docetaxel	Three-weekly chemotherapy
A	capecitabine	Three-weekly chemotherapy
B	docetaxel	Weekly chemotherapy
B	capecitabine	Weekly chemotherapy

Primary Outcome Measures

Name	Time	Method
quality of life	during first 6 weeks of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Response rate	After 12 and 24 weeks of chemotherapy
Toxicity	every 3 weeks
overall survival	2 years

Trial Locations

Locations (3)

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B; 🇮🇹 Napoli, Italy

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C; 🇮🇹 Napoli, Italy

Ospedale S. Luca ASL SA 3; 🇮🇹 Vallo della Lucania, Italy