Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

Study Overview
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Brief Summary
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The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days

Detailed Description
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Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. The women in this study will receive either 5 or 3 radiation fractions to the tumor bed. We have chosen to study T1 post menopausal women because in this subset: 1) the tumor is small enough to be treated by partial breast radiation 2) the odds of having multicentric disease are low, making it ethical to avoid whole breast irradiation, 3) the most benefit from reducing the radiation schedule from 5 to 3 could be expected. All patients will receive either 8 Gy x 3 over 5 days, every other day or 6 Gy x 5 over 5 days, on five consecutive days

Official Title
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Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: PBI Radiotherapy 6 Gy
* Radiation: PBI Radiotherapy 8 Gy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal women defined as either: at least 2 years without menstrual period patients older than 50 with serological evidence of post-menopausal status hysterectomized patients of any age with FSH confirmation of post- menopausal status pT1 breast cancer, excised with negative margins clinically N0 or pN0 or sentinel node negative breast cancer Exclusion Criteria: previous radiation therapy to the ipsilateral breast presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBI Radiotherapy 6 Gy<br>Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days | Radiation: PBI Radiotherapy 6 Gy<br>* Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days<br>* Other names: Prone partial breast irradiation;|
| Experimental: PBI Radiotherapy 8 Gy<br>Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day | Radiation: PBI Radiotherapy 8 Gy<br>* Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day<br>* Other names: Prone partial breast irradiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence rate at 5 years | We will measure non-inferiority to the current 1% local recurrence rate at 5 years | 48 - 60 months | 
| Fibrosis rate at 5 years | We will measure the non-inferiority to the 5 year fibrosis rate of 24-36% | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolated local/regional recurrences | At the time of local recurrence, patients will undergo disease assessment and will be further grouped as: Isolated local/regional recurrence Concomitant local/regional and distant recurrence | 48-60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PBI, breast, cancer, breast cancer, prone, partial breast irradiation