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HER2-targeted Therapy

Radiation and HER2-Targeted Therapy for Breast Cancer (HERO Trial)

Phase 3
Recruiting
Led By Norman Wolmark, MD
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For the Neoadjuvant cohort, neoadjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy
Tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of randomization for the duration of the trial at 10.5 years.
Awards & highlights

HERO Trial Summary

This trial compares outcomes of breast cancer patients who get radiation vs. those who don't, after surgery and other HER2-directed therapies.

Who is the study for?
This trial is for men and women aged 40 or older with early-stage, low-risk HER2-positive breast cancer who've had breast conserving surgery and at least 12 weeks of chemo with HER2-targeted therapy. They must have no metastatic disease, negative lymph nodes, and be HIV-positive on effective treatment if applicable. Pregnant or breastfeeding individuals are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of standard HER2-targeted therapy alone versus combining it with adjuvant breast radiation in preventing cancer recurrence after surgery. Participants will either receive additional radiotherapy per standard care or not, alongside their ongoing HER2-directed treatments.See study design
What are the potential side effects?
HER2-targeted therapies can cause heart problems, allergic reactions, flu-like symptoms, diarrhea and rashes. Radiation may lead to skin changes like redness and irritation in the treated area as well as fatigue.

HERO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I received at least 12 weeks of chemo and HER2 therapy before surgery.
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My tumor is HER2-positive according to the latest guidelines.
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My breast cancer diagnosis was confirmed through tissue examination.
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I've completed at least 12 weeks of chemo and HER2 therapy after breast-saving surgery.
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I am 40 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My tumor is HER2-positive according to the latest guidelines.
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My cancer stage fits the AJCC 8th edition criteria.
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My breast cancer was small (<=2 cm), had not spread to nearby lymph nodes, and was completely removed with surgery.
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I received at least 12 weeks of chemo and HER2 therapy after my cancer surgery.

HERO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of randomization for the duration of the trial at 10.5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of randomization for the duration of the trial at 10.5 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
recurrence-free interval (RFI)
Secondary outcome measures
disease-free survival (DFS) by treatment arm.
ipsilateral breast recurrence (IBR) by treatment arm
ipsilateral breast recurrence (IBR) for radiation omitting arm
+4 more

HERO Trial Design

2Treatment groups
Active Control
Group I: Standard of Care Adjuvant Breast RadiationActive Control1 Intervention
Patients continue to receive their current planned adjuvant breast radiation and systemic HER2-targeted therapies
Group II: Standard of Care HER2-targeted Therapy Without Adjuvant Breast RadiationActive Control1 Intervention
Patients continue to receive their current systemic HER2-targeted therapy without breast adjuvant radiation

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
260,511 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,925,502 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyOTHER
512 Previous Clinical Trials
216,338 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer

Media Library

Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation (HER2-targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05705401 — Phase 3
Breast Cancer Research Study Groups: Standard of Care Adjuvant Breast Radiation, Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
Breast Cancer Clinical Trial 2023: Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation Highlights & Side Effects. Trial Name: NCT05705401 — Phase 3
Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation (HER2-targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705401 — Phase 3

Frequently Asked Questions

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

Is the Standard of Care Adjuvant Breast Radiation protocol sanctioned by the FDA?

"The efficacy and safety of Standard of Care Adjuvant Breast Radiation have been well-documented, thus it was assigned a rating of 3 on the scale."

Answered by AI

Are there any current openings to participate in this experiment?

"Clinicaltrials.gov presents that this trial is not presently recruiting for participants, despite having been initially posted on March 13th 2023 and last updated April 12th of the same year. However, 2344 other studies are actively seeking patients at present."

Answered by AI

Who else is applying?

What site did they apply to?
Kaiser San Rafael-Gallinas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
2023. "Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05705401.
All > Breast Cancer Glendale > Honolulu
~867 spots leftby Feb 2034
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