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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
Must not have
Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active systemic lupus erythematosus, or scleroderma
On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination
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
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active collagen disease like lupus, scleroderma, or dermatomyositis with high CPK.
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My breast cancer tumor was larger than 2 cm after surgery, or larger than 3 cm before surgery with suspicious lymph nodes.
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My breast cancer is in more than one area but all areas are within a 3 cm space.
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I have Paget's disease of the nipple.
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My cancer has spread to other parts of my body.
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My cancer has spread to the lymph nodes in my armpit.
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I have suspicious breast changes not yet proven benign by biopsy.
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I am not currently using any form of estrogen replacement therapy.
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My treatment plan includes radiation therapy to the lymph nodes.
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My scans show suspicious lymph nodes near my breast without confirmed spread.
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I am planning to have or have already had a mastectomy.
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My breast cancer is not the common type; it's a rare form like sarcoma or lymphoma.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
recurrence-free interval (RFI)
Secondary study objectives
disease-free survival (DFS) by treatment arm.
ipsilateral breast recurrence (IBR) by treatment arm
ipsilateral breast recurrence (IBR) for radiation omitting arm
+4 more

Awards & Highlights

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

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
259,887 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,898 Previous Clinical Trials
41,011,413 Total Patients Enrolled
947 Trials studying Breast Cancer
1,545,598 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyOTHER
515 Previous Clinical Trials
218,576 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
~867 spots leftby Feb 2034
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