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Completed

NCT Number: NCT00540800

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Naples, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

given in combination with epirubicin or capecitabine

Epirubicin

Drug

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

Capecitabine

Drug

for metastatic breast cancer patients previously treated with anthracyclines

Primary outcomes

  1. quality of life

    Time frame: during first 6 weeks of chemotherapy

Secondary outcomes

  1. Response rate

    Time frame: After 12 and 24 weeks of chemotherapy

  2. Toxicity

    Time frame: every 3 weeks

  3. overall survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Acronym: BREAST-10

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2007
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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