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

Breast Cancer Clinical Trial

— BREAST-10  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540800
• Other study ID #: BREAST-10
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: January 13, 2016
• Start date: February 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel
given in combination with epirubicin or capecitabine
• epirubicin
for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines
• capecitabine
for metastatic breast cancer patients previously treated with anthracyclines

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B	Napoli
Italy	Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Napoli
Italy	Ospedale S. Luca ASL SA 3	Vallo della Lucania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life		during first 6 weeks of chemotherapy	No
Secondary	Response rate		After 12 and 24 weeks of chemotherapy	No
Secondary	Toxicity		every 3 weeks	Yes
Secondary	overall survival		2 years	No