A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: capecitabine [Xeloda]; Drug: Taxotere

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089479

NO17629

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Enrollment: 2,611 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients 18-70 years of age;
• adenocarcinoma of the breast;
• previous invasive breast cancer if diagnosed >5 years before entering study;
• no evidence of metastatic disease.

Exclusion criteria

• history of severe hypersensitivity reaction to Taxotere;
• previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
• treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,611 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Taxotere

Drug: Taxotere

Drug: capecitabine [Xeloda]

2

Active Comparator group

Treatment:

Drug: Taxotere

Drug: Taxotere