APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer

Study Overview
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Brief Summary
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To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Detailed Description
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To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Official Title
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Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Accelerated partial breast irradiation
* Radiation: External beam whole breast irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 0, I or II breast cancer. Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma. Ductal carcinoma in situ (DCIS) alone. No lymph invasion (L0) and no hemangiosis (V0). Lesions of > 3 cm diameter, histopathologically confirmed. pN0/pNmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of DCIS alone axillary staging (e.g. sentinel lymph node biopsy) is optional. M0. Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm. For DCIS only: lesions must be classified as low or intermediate risk group (Van Nuys Prognostic Index <8). Unifocal and unicentric DCIS or breast cancer. Age >= 40 years. Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy. Signed study-specific consent form prior to randomization. Exclusion Criteria: Stage III or IV breast cancer. Surgical margins that cannot be microscopically assessed. Extensive intraductal component (EIC). Paget's disease or pathological skin involvement. Synchronous or previous breast cancer. Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma FIGO 0 and I if patient is continuously disease-free. Pregnant or lactating women. Collagen vascular disease. The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar. Psychiatric disorders. Patient with breast deemed technically unsatisfactory for brachytherapy.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APBI<br>Accelerated Partial Breast Irradiation with multicatheter brachytherapy | Radiation: Accelerated partial breast irradiation<br>* APBI with PDR and HDR brachytherapy<br>|
| Active Comparator: EBRT<br>Standard External Beam Whole Breast Irradiation | Radiation: External beam whole breast irradiation<br>* Standard Whole breast irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control |  | 5-years, 10 ten-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of acute and late side effects |  | 5-years | 
| Differences in cosmetic results |  | 5-years | 
| Distant metastases free survival |  | 5-years | 
| Survival rates (Overall Survival, Disease-free Survival) |  | 5-years | 
| Contralateral breast cancer rate |  | 5-years | 
| Quality-of-Life |  | 5-years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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accelerated partial breast irradiation, multicatheter brachytherapy, high dose rate brachytherapy, pulsed dose rate brachytherapy