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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


Phase 3
N/A
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

quality of life

Outcome Time Frame:

during first 6 weeks of chemotherapy

Principal Investigator

Andrea de Matteis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Medical Oncology C

Authority:

Italy: Ethics Committee

Study ID:

BREAST-10

NCT ID:

NCT00540800

Start Date:

February 2004

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • anthracycline pre-treated
  • chemotherapy
  • first-line
  • metastatic breast cancer
  • locally advanced breast cancer
  • Breast Neoplasms

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