Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.

Official Title
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Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic

Conditions
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Breast Cancer, HER2-positive Breast Cancer

Intervention / Treatment
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* Other: Omit breast radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age ≥ 40 years Patients must have a tissue diagnosis of HER2+ breast cancer Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection. Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis) Exclusion Criteria: Breastfeeding Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast Prior adjuvant radiation therapy Patients with diagnosis of inflammatory breast cancer Patients with known BRCA mutation or other known breast cancer related deleterious mutations

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omit breast radiation<br> | Other: Omit breast radiation<br>* Omit breast radiation for 3 years after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial | Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial. | At time of consent. Assessed up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2, partial mastectomy, lumpectomy, sentinel node biopsy, axillary node dissection, pathologic complete response, breast cancer, HER2-positive