BREAST-10: Three-Weekly Versus Weekly First-Line Chemotherapy for Metastatic or Locally Advanced Breast Cancer - Full Text View

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00540800

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Docetaxel Capecitabine

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

Arms	Assigned Interventions
A: Active Comparator 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
B: Experimental 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

Study ID Numbers:	BREAST-10
Study First Received:	October 5, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00540800 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Docetaxel
Anti-Bacterial Agents
Capecitabine
Skin Diseases

Quality of Life
Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Breast Neoplasms

Antibiotics, Antineoplastic
Epirubicin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on August 28, 2009