CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 596 enrolled
Drug / intervention
5-Fluorouracil +5 moredrug
Likely dose
5-Fluorouracil 500 milligramsfrom 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/NCT00950300
NCT00950300Phase 3Completed
CompareCT.gov

A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)

Hoffmann-La Roche·interventional·Posted Jul 31, 2009·Updated Jan 23, 2018

In Brief

A Phase 3 clinical trial evaluating 5-Fluorouracil, Cyclophosphamide, and 4 other interventions for Breast Cancer. Completed, enrolled 596 participants across 106 sites in 26 countries.

Detailed Summary

In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Brazil, Canada, Colombia, Czechia, Estonia, France, Germany, Guatemala, Hong Kong, Hungary, Israel, Italy, Mexico, Panama, Peru, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 31, 2009
Enrollment StartOct 16, 2009
Primary CompletionJul 12, 2011
Study CompletionJan 24, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.9 years ago

Interventions

5-Fluorouracildrug

Participants will receive 5-fluorouracil, 500 milligrams per meter-squared (mg/m\^2) via IV bolus or infusion, on Day 1 of every 21-day cycle during Cycles 5 to 8.

Cyclophosphamidedrug

Participants will receive cyclophosphamide, 500 mg/m\^2 via IV bolus, on Day 1 of every 21-day cycle during Cycles 5 to 8.

Docetaxeldrug

Participants will receive docetaxel, 75 mg/m\^2 via IV infusion on Day 1 of every 21-day cycle during Cycles 1 to 4.

Epirubicindrug

Participants will receive epirubicin, 75 mg/m\^2 via IV bolus or infusion, on Day 1 of every 21-day cycle during Cycles 5 to 8.

Herceptin IV [trastuzumab]drug

Herceptin will be administered as 8 mg/kg (loading dose during Cycle 1) and 6 mg/kg (subsequent cycles) via IV infusion on Day 1 of each 21-day cycle for a total of 18 cycles.

Herceptin SC [trastuzumab]drug

Herceptin will be administered as fixed dose 600 mg SC on Day 1 of each 21-day cycle for a total of 18 cycles.