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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: epirubicin
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Three-weekly chemotherapy | Drug: docetaxel<br>* given in combination with epirubicin or capecitabine<br>Drug: epirubicin<br>* for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines<br>Drug: capecitabine<br>* for metastatic breast cancer patients previously treated with anthracyclines<br>|
| Experimental: B<br>Weekly chemotherapy | Drug: docetaxel<br>* given in combination with epirubicin or capecitabine<br>Drug: epirubicin<br>* for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines<br>Drug: capecitabine<br>* for metastatic breast cancer patients previously treated with anthracyclines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | during first 6 weeks of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | After 12 and 24 weeks of chemotherapy | 
| Toxicity |  | every 3 weeks | 
| overall survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthracycline pre-treated, chemotherapy, first-line, metastatic breast cancer, locally advanced breast cancer