CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,099 enrolled
Drug / intervention
Herceptin +1 moredrug
Likely dose
Herceptin 8 mg/kg IV loading dose on Day 1, then 6 mg/kg IV every 3 weeksAI-extracted
Key inclusion· 4
  • ✓Non-metastatic primary invasive breast cancer with HER2 overexpression (IHC 3+ or positive FISH)
  • ✓Completion of at least 4 cycles of (neo-)adjuvant chemotherapy, definitive surgery, and radiotherapy if applicable
  • ✓Known hormone receptor status documented
  • ✓Baseline left ventricular ejection fraction (LVEF) ≥55%
Key exclusion· 9
  • ✕Prior invasive breast carcinoma
  • ✕Other active malignancies (except curatively treated basal/squamous cell skin cancer or in situ cervical carcinoma)
  • ✕Clinical T4 tumors
  • ✕Cumulative doxorubicin >360 mg/m² or epirubicin >720 mg/m² or prior anthracyclines unrelated to current breast cancer

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

Search/NCT00045032
NCT00045032Phase 3Completed
CompareCT.gov

A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

Hoffmann-La Roche·interventional·Posted Jan 27, 2003·Updated Apr 27, 2017

In Brief

A Phase 3 clinical trial evaluating Herceptin for Breast Cancer. Completed, enrolled 5,099 participants across 203 sites in 33 countries.

Detailed Summary

The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom
CollaboratorsBreast International Group, European Organisation for Research and Treatment of Cancer - EORTC, NCIC Clinical Trials Group, ETOP IBCSG Partners Foundation

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 2001
Primary CompletionMar 1, 2005
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 23.4 years ago

Interventions

Herceptindrug

Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.

Herceptindrug

Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.