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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of randomization for the duration of the trial at 10.5 years.

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.