CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 157 enrolled
Drug / intervention
capecitabine [Xeloda] +4 moredrug
Likely dose
Capecitabine (Xeloda) 825 mg/m² orally twice daily on days 1–14 of each 3-week cycle plus Taxotere (docetaxel) 75 mg/m² IV on day 1 of each 3-week cycle; for HER2-positive patients, add Herceptin (trastuzumab) 4 mg/kg IV loading dose followed by 2 mg/kg IV weeklyAI-extracted
Key inclusion· 3
  • ✓Women aged 18 years or older
  • ✓Newly diagnosed breast cancer
  • ✓Invasive (infiltrating) breast cancer, either HER2-negative or HER2-positive
Key exclusion· 2
  • ✕Metastatic disease is excluded, except for same-side (ipsilateral) axillary lymph node involvement
  • ✕Prior systemic or local primary treatment for breast cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127933
NCT00127933Phase 4Completed
CompareCT.gov

An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer

Hoffmann-La Roche·interventional·Posted Aug 9, 2005·Updated Aug 10, 2011

In Brief

A Phase 4 clinical trial evaluating capecitabine [Xeloda], Taxotere, and 1 other intervention for Breast Cancer. Completed, enrolled 157 participants across 38 sites.

Detailed Summary

This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2005
Enrollment StartAug 1, 2005
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.9 years ago

Interventions

capecitabine [Xeloda]drug

825mg/m2 po bid on days 1-14 of each 3 week cycle

Taxoteredrug

75mg/m2 iv on day 1 of each 3 week cycle

Herceptin (HER2-neu positive patients only)drug

4mg/kg iv (loading dose) followed by 2mg/kg iv weekly

capecitabine [Xeloda]drug

825mg/m2 po bid on days 1-14 of each 3 week cycle

Taxoteredrug

75mg/m2 iv on day 1 of each 3 week cycle