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

January 13, 2016 updated by: National Cancer Institute, Naples

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
      • Vallo della Lucania, Italy
        • Ospedale S. Luca ASL SA 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: during first 6 weeks of chemotherapy
during first 6 weeks of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2 years
2 years
Toxicity
Time Frame: every 3 weeks
every 3 weeks
Response rate
Time Frame: After 12 and 24 weeks of chemotherapy
After 12 and 24 weeks of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Francesco Perrone, M.D., Ph.D., NCI Naples, Clinical Trials Office

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREAST-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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