At a glance
ClinicalIndex Comparison Record- ✓Female patients aged 18–70 years
- ✓Adenocarcinoma of the breast
- ✓No evidence of metastatic disease
- ✓Prior invasive breast cancer allowed if diagnosed >5 years before study entry
- ✕History of severe hypersensitivity reaction to Taxotere
- ✕Prior treatment with anthracycline, anthracenedione (mitoxantrone), or taxane
- ✕Fluoropyrimidine (5-fluorouracil) treatment within the last 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
In Brief
A Phase 3 clinical trial evaluating capecitabine [Xeloda] and Taxotere for Breast Cancer. Completed, enrolled 2,611 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
825mg/m2 po bid on days 1-14 of each 3 week cycle
75mg/m2 iv on day 1 of each 3 week cycle
100mg/m2 iv on day 1 of each 3 week cycle