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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: docetaxel
Drug: epirubicin
Drug: capecitabine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • quality of life [ Time Frame: during first 6 weeks of chemotherapy ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: After 12 and 24 weeks of chemotherapy ]
  • Toxicity [ Time Frame: every 3 weeks ]
  • overall survival

Estimated Enrollment: 280
Study Start Date: February 2004
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Three-weekly chemotherapy
 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
Experimental: B
Weekly chemotherapy
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540800

Locations
Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Ospedale S. Luca ASL SA 3
Vallo della Lucania, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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
  More Information

No publications provided by National Cancer Institute, Naples

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Francesco Perrone, National Cancer Institute Naples
ClinicalTrials.gov Identifier: NCT00540800     History of Changes
Other Study ID Numbers: BREAST-10
Study First Received: October 5, 2007
Last Updated: August 4, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
anthracycline pre-treated
chemotherapy
first-line
metastatic breast cancer
locally advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Docetaxel
Capecitabine
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013