Study of Stereotactic Radiotherapy for Breast Cancer

Study Overview
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Brief Summary
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This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

Detailed Description
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This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.

Official Title
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A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female sex Age > or = to 50 years of age Invasive ductal carcinoma Clinically and radiographically T1 tumor Clinically node negative Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior) Planning breast conserving surgery including sentinel node biopsy ≥10% expression of ER and/or PR HER2- using the current College of American Pathologists guidelines Post-menopausal Willing and able to provide informed consent Exclusion Criteria: Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma Pure DCIS without invasive cancer Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment Positive pregnancy test Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. Unable to meet dosimetric constraints due to tumor location and/or patient anatomy Planning mastectomy Unable to tolerate prone positioning

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 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
Interventional Model Description: SBRT to the breast follow by standard of care surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT to the breast then surgery<br>Stereotactic Body Radiation of 21 gy followed by standard of care surgery | Radiation: Stereotactic Body Radiation SBRT<br>* Stereotactic Body Radiation to the breast to 21 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response | To determine the rate of Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)) and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors. | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of treatment-related toxicity | To determine the rate of severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery. | 90 days | 
| The rate of cosmetic outcome | To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 3 years after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images. | 90 days | 
| The time to recurrence | To measure local recurrence rate | 1 year | 
| Quality of Life | To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early stage, low risk