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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00540800
First received: October 5, 2007
Last updated: August 4, 2011
Last verified: August 2011
History of Changes

October 5, 2007
August 4, 2011
February 2004
September 2009   (final data collection date for primary outcome measure)
quality of life [ Time Frame: during first 6 weeks of chemotherapy ]
Same as current
Complete list of historical versions of study NCT00540800 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: After 12 and 24 weeks of chemotherapy ]
  • Toxicity [ Time Frame: every 3 weeks ]
  • overall survival
Same as current
Not Provided
Not Provided
 
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: docetaxel
    given in combination with epirubicin or capecitabine
  • Drug: epirubicin
    for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines
  • Drug: capecitabine
    for metastatic breast cancer patients previously treated with anthracyclines
  • Active Comparator: A
    Three-weekly chemotherapy
    Interventions:
    • Drug: docetaxel
    • Drug: epirubicin
    • Drug: capecitabine
  • Experimental: B
    Weekly chemotherapy
    Interventions:
    • Drug: docetaxel
    • Drug: epirubicin
    • Drug: capecitabine
Nuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, D'Aiuto G, Thomas R, Rinaldo M, Botti G, Di Bonito M, Di Maio M, Gallo C, Perrone F, de Matteis A. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial. BMC Cancer. 2011 Feb 16;11:75.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00540800
BREAST-10
No
Francesco Perrone, National Cancer Institute Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Andrea de Matteis, M.D. NCI Naples, Division of Medical Oncology C
Principal Investigator: Francesco Perrone, M.D., Ph.D. NCI Naples, Clinical Trials Office
National Cancer Institute, Naples
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP