Clinical trial NCT00540800: BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: anthracycline pre-treated
chemotherapy
first-line
metastatic breast cancer
locally advanced breast cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2007-10-08
Enrollment: 139
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: quality of life
timeFrame: during first 6 weeks of chemotherapy
Secondary outcomes:
measure: Response rate
timeFrame: After 12 and 24 weeks of chemotherapy
measure: Toxicity
timeFrame: every 3 weeks
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
city: Vallo della Lucania
country: Italy
facility: Ospedale S. Luca ASL SA 3
Study officials:
affiliation: NCI Naples, Division of Medical Oncology C
name: Andrea de Matteis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples, Clinical Trials Office
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1471-2407-11-75.