A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: capecitabine (Xeloda®); Drug: docetaxel (Taxotere®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077857

NO16853

Details and patient eligibility

About

This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.

Enrollment: 470 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women >=18 years of age;
• >=1 target lesion;
• locally advanced or metastatic breast cancer;
• demonstrated resistance to anthracycline;
• >=2 regimens of chemotherapy for advanced/metastatic disease.

Exclusion criteria

• previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
• previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

1250 mg/m^2 capecitabine + docetaxel

Experimental group

Description:

1250 mg/m\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.

Treatment:

Drug: capecitabine (Xeloda®)

Drug: docetaxel (Taxotere®)

825 mg/m^2 capecitabine + docetaxel

Experimental group

Description:

825 mg/m\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.

Treatment:

Drug: capecitabine (Xeloda®)

Drug: docetaxel (Taxotere®)