NCT00769379

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,014 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (IIBCR-SCR-DCIS) in women with human epidermal growth factor receptor 2 (HER2)-positive DCIS resected by lumpectomy. SECONDARY OBJECTIVES: I. Determine the value of trastuzumab given during RT compared to RT alone in prolonging invasive or DCIS disease-free survival (IDFS)-DCIS. II. Determine the value of trastuzumab given during RT compared to RT alone in increasing invasive or DCIS recurrence-free interval. III. Determine the value of trastuzumab given during RT compared to RT alone in improving regional or distant recurrence. IV. Determine the value of trastuzumab given during RT compared to RT alone in improving the incidence of contralateral invasive or DCIS breast cancer. V. Determine the value of trastuzumab given during RT compared to RT alone in improving survival. VI. To explore the effect of trastuzumab on ovarian function. TERTIARY OBJECTIVES: I. To determine if the benefit of trastuzumab added to RT will be significantly higher in v-myc avian myelocytomatosis viral oncogene homolog (cMYC)-amplified tumors than in the cMYC non-amplified subset. II. To determine if the benefit of trastuzumab added to RT will be less in tumors with mutations in the phosphatidylinositol 3 (PI3) kinase gene than in tumors without PI3 kinase gene mutations. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard whole breast irradiation (WBI) over 5-6 weeks. ARM II: Patients receive trastuzumab intravenously (IV) over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. After completion of study treatment, patients are followed up every 6 months for 5 years and then every 12 months for 5 years.

Conditions

• Breast Ductal Carcinoma In Situ

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Trastuzumab	Given IV
RADIATION	Whole Breast Irradiation	Undergo standard whole breast irradiation

Timeline

• Start date: 2008-12-10
• Primary completion: 2019-12-31
• Completion: 2025-06-02
• First posted: 2008-10-09
• Last updated: 2025-06-12
• Results posted: 2022-02-23

Locations

1,260 sites across 4 countries: United States, Canada, Puerto Rico, South Korea