Single Dose Partial Breast Radiotherapy

Study Overview
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Brief Summary
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This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.

Detailed Description
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This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts. Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.

Official Title
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Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery) Clinical T1N0M0 55 years of age or older Estrogen receptor (ER) positive, No evidence of lymphovascular space invasion on initial biopsy Not pregnant. If not post-menopausal must adhere to birth control measures White blood cell count > 3000, Hemoglobin > 9, platelets >100000 Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min Exclusion Criteria: Neoadjuvant chemotherapy Breast implants Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma) Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length HER-2/neu positive Positive serum pregnancy test

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose radiosurgery: Dose Level 1<br>A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. | Radiation: Radiosurgery<br>* Single dose or radiation in 15Gy, 18Gy or 21Gy<br>* Other names: External beam radiation therapy;|
| Experimental: Single dose radiosurgery: Dose Level 2<br>A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. | Radiation: Radiosurgery<br>* Single dose or radiation in 15Gy, 18Gy or 21Gy<br>* Other names: External beam radiation therapy;|
| Experimental: Single dose radiosurgery: Dose Level 3<br>A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. | Radiation: Radiosurgery<br>* Single dose or radiation in 15Gy, 18Gy or 21Gy<br>* Other names: External beam radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose | As measured by the incidence of acute toxicity and wound healing complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Outcome | Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size. | 3 years | 
| Local Control |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of Breast, Cancer of the Breast, Neoplasms, Breast, Single dose radiation, Radiotherapy, Preoperative