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Radiation Therapy + Trastuzumab for Breast Cancer

Phase 3
Waitlist Available
Led By Melody A Cobleigh
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
On histologic examination, the tumor must be ductal carcinoma in situ (DCIS)
Must not have
Prior history of breast cancer, including DCIS
Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

Who is the study for?
This trial is for women who've had a lumpectomy to remove ductal carcinoma in situ (DCIS) that's HER2-positive. They should have no DCIS at the surgery margins, be cancer-free elsewhere, and not pregnant or breastfeeding. Participants must be relatively healthy with an ECOG status of 0 or 1 and able to follow up long-term.
What is being tested?
The study compares radiation therapy alone versus radiation combined with Trastuzumab, a monoclonal antibody that targets tumor cells. It aims to discover if adding Trastuzumab improves treatment outcomes for HER2-positive DCIS after lumpectomy.
What are the potential side effects?
Trastuzumab can cause heart problems, allergic reactions, flu-like symptoms, nausea, diarrhea, and fatigue. Radiation may lead to skin changes like redness and irritation in the treated area as well as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is classified as DCIS.
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My DCIS is HER2-positive based on specialized testing.
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My surgery removed all the cancerous cells.
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My lymph nodes are cancer-free or only microscopically affected.
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I had surgery to remove a non-invasive breast cancer.
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My last surgery for DCIS was within the last 4 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had breast cancer or DCIS before.
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I have suspicious masses or calcifications that have not been biopsied.
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I have cancer in both breasts.
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My blood pressure is not controlled by medication.
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My breast cancer is invasive, even if it's very small.
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I have received whole breast radiation before being considered for this study.
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My cancer has spread to nearby lymph nodes.
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My breast cancer is present in more than one area.
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I have received anthracycline chemotherapy before.
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I don't have any health conditions that would stop me from getting certain cancer treatments or attending follow-up visits.
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I do not have heart conditions that would prevent me from taking certain cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival
Secondary study objectives
Contralateral Breast Cancer (Invasive or DCIS) - Free Survival
Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry
Invasive Regional or Distant-Free Recurrence
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (WBI, trastuzumab)Experimental Treatment3 Interventions
Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.
Group II: Arm I (standard WBI)Experimental Treatment2 Interventions
Patients undergo standard WBI over 5-6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Whole Breast Irradiation
2017
N/A
~160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,110,073 Total Patients Enrolled
NRG OncologyOTHER
239 Previous Clinical Trials
101,151 Total Patients Enrolled
Melody A CobleighPrincipal InvestigatorNRG Oncology

Media Library

Whole Breast Irradiation Clinical Trial Eligibility Overview. Trial Name: NCT00769379 — Phase 3
DCIS Research Study Groups: Arm I (standard WBI), Arm II (WBI, trastuzumab)
DCIS Clinical Trial 2023: Whole Breast Irradiation Highlights & Side Effects. Trial Name: NCT00769379 — Phase 3
Whole Breast Irradiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT00769379 — Phase 3
~118 spots leftby Dec 2025
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