CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,014 enrolled
Drug / intervention
Trastuzumab +2 morebiological
Likely dose
Not stated in 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/NCT00769379
NCT00769379Phase 3Completed

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

National Cancer Institute (NCI)·interventional·Posted Oct 9, 2008·Updated Jun 12, 2025

In Brief

A Phase 3 clinical trial evaluating Laboratory Biomarker Analysis, Trastuzumab, and 1 other intervention for Breast Ductal Carcinoma In Situ. Completed, enrolled 2,014 participants across 1,260 sites in 4 countries.

Detailed Summary

This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Puerto Rico, South Korea, United States
CollaboratorsNRG Oncology

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2008
Enrollment StartDec 10, 2008
Primary CompletionDec 31, 2019
Study CompletionJun 2, 2025
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 17.7 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Trastuzumabbiological

Given IV

Whole Breast Irradiationradiation

Undergo standard whole breast irradiation