CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 225 enrolled
Drug / intervention
Xeloda +2 moredrug
Likely dose
Xeloda 950 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02748213
NCT02748213Phase 2Completed
CompareCT.gov

An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2

Hoffmann-La Roche·interventional·Posted Apr 22, 2016·Updated Nov 22, 2016

In Brief

A Phase 2 clinical trial evaluating Xeloda, Taxotere, and 1 other intervention for Breast Cancer. Completed, enrolled 225 participants across 51 sites in 15 countries.

Detailed Summary

This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Brazil, Canada, Costa Rica, Finland, France, Greece, Guatemala, Italy, Mexico, Panama, Poland, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2016
Enrollment StartFeb 1, 2002
Primary CompletionMar 1, 2006
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.2 years ago

Interventions

Xelodadrug

Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle.

Taxoteredrug

Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.

Herceptindrug

Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.