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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

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

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,842 Previous Clinical Trials

41,000,986 Total Patients Enrolled

945 Trials studying Breast Cancer

1,543,964 Patients Enrolled for Breast Cancer

NRG OncologyOTHER

236 Previous Clinical Trials

100,261 Total Patients Enrolled

9 Trials studying Breast Cancer

11,639 Patients Enrolled for Breast Cancer

Melody A CobleighPrincipal InvestigatorNRG Oncology

Media Library

Whole Breast Irradiation Clinical Trial Eligibility Overview. Trial Name: NCT00769379 — Phase 3

Breast Cancer Research Study Groups: Arm I (standard WBI), Arm II (WBI, trastuzumab)

Breast Cancer 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

~120 spots leftby Sep 2025

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