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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Three-weekly chemotherapy

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

given in combination with epirubicin or capecitabine

epirubicin

Intervention Type DRUG

for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines

capecitabine

Intervention Type DRUG

for metastatic breast cancer patients previously treated with anthracyclines

B

Weekly chemotherapy

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

given in combination with epirubicin or capecitabine

epirubicin

Intervention Type DRUG

for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines

capecitabine

Intervention Type DRUG

for metastatic breast cancer patients previously treated with anthracyclines

Interventions

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docetaxel

given in combination with epirubicin or capecitabine

Intervention Type DRUG

epirubicin

for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines

Intervention Type DRUG

capecitabine

for metastatic breast cancer patients previously treated with anthracyclines

Intervention Type DRUG

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

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No