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

National Cancer Institute, Naples139 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Breast Cancer

Interventions

docetaxelDRUG

given in combination with epirubicin or capecitabine

epirubicinDRUG

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

capecitabineDRUG

for metastatic breast cancer patients previously treated with anthracyclines

Eligibility

Sex: FEMALEMax age: 70 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

quality of life

Time frame: during first 6 weeks of chemotherapy

Secondary Outcomes

Response rate

Time frame: After 12 and 24 weeks of chemotherapy

Toxicity

Time frame: every 3 weeks

overall survival

Time frame: 2 years

Data from ClinicalTrials.gov

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