← Back to Search

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My breast cancer is classified as DCIS.

Select...

My DCIS is HER2-positive based on specialized testing.

Select...

My surgery removed all the cancerous cells.

Select...

My lymph nodes are cancer-free or only microscopically affected.

Select...

I had surgery to remove a non-invasive breast cancer.

Select...

My last surgery for DCIS was within the last 4 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival

Secondary outcome measures

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,931,139 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

NRG OncologyOTHER

231 Previous Clinical Trials

98,838 Total Patients Enrolled

9 Trials studying Breast Cancer

11,638 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this research?

"The primary goal of this long-term study is to compare the rates of ipsilateral Invasive Breast cancer, Ipsilateral Skin cancer Recurrence, or Ipsilateral DCIS-Free Survival among different treatment groups. Secondary outcome measures include the Invasive or DCIS Recurrence-free Interval, which will be analyzed using Cox proportional hazards models, and the Kaplan-Meier method. The percentage of patients who are invasive or DCIS recurrence free will also be calculated, as well as theInvasion or DCIS disease-free survival."

Answered by AI

Is Whole Breast Irradiation a high-risk treatment?

"Whole Breast Irradiation has been shown to be safe in multiple clinical trials, so it receives a score of 3."

Answered by AI

How large is the sample size for this experiment?

"This particular trial is no longer looking for new participants. It was originally posted on November 10th, 2008 but the most recent edit was made on October 18th, 2022. However, there are 2615 trials actively recruiting patients with carcinoma and 203 trials seeking whole breast irradiation patients that are currently accepting applications."

Answered by AI

In how many different hospitals is this medical study being conducted today?

"There are 100 clinical trial sites around the world testing this medication. If you choose to participate in the study, it would be most convenient for you to pick a location nearest to minimize travel time and complications."

Answered by AI

What is the general consensus in the medical community regarding Whole Breast Irradiation?

"Whole Breast Irradiation was first trialed in 1999 at Ospedale di Circolo e Fondazione Macchi. Since the initial study, 917 others have been completed with 203 more presently underway. Many of these active trials are based out of Orange, CA."

Answered by AI

Are we still accepting patients for this trial?

"This specific clinical trial is not currently admitting patients. However, it was most recently edited on October 18th, 2022. If you are looking for other trials, 2615 different studies involving carcinoma, ductal and 203 studies for Whole Breast Irradiation are actively seeking participants."

Answered by AI

What malady does Whole Breast Irradiation typically address?

"Whole Breast Irradiation, while most often used to treat breast cancer, can also be a useful treatment for other conditions including when there is a high risk of recurrence or surgery has been ineffective."

Answered by AI

Recent research and studies

in SituJournal

Ductal Carcinoma<i>in Situ</i>: An Overview

Duggal, Shivani, Julieta Robin, and Thomas B Julian. 2013. “Ductal Carcinomain Situ: An Overview”. Expert Review of Anticancer Therapy. Informa UK Limited. doi:10.1586/14737140.2013.820557.

Journal of Clinical OncologyJournal

Comparison of Radiation with or Without Concurrent Trastuzumab for Her2-positive Ductal Carcinoma in Situ Resected by Lumpectomy: A Phase III Clinical Trial

Cobleigh, Melody A., Stewart J. Anderson, Kalliopi P. Siziopikou, Douglas W. Arthur, Rachel Rabinovitch, Thomas B. Julian, David S. Parda, et al.. 2021. “Comparison of Radiation with or Without Concurrent Trastuzumab for Her2-positive Ductal Carcinoma in Situ Resected by Lumpectomy: A Phase III Clinical Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02824.

clinicaltrials.govStudy

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

2008. "Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00769379.

All > Basal Cell Carcinoma > Dcis