Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Study Overview
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Brief Summary
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Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).

Detailed Description
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The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected. All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard. Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).

Official Title
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a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: breast/chest wall radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes. pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed; ECOG Performance status ≤2; histologically negative surgical margins no distant metastases no prior chest radiotherapy life expectancy ≥ 5 years no prior cancer Exclusion Criteria: Non-epithelial breast cancer (sarcoma, lymphoma etc.) Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed pT4 neoplasms or inflammatory breast carcinoma Distant metastasis Concomitant chemotherapy history of prior controlateral breast tumor

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: breast/chest wall radiotherapy|34 Gy/10 fxs/2 wks to the whole breast/chest wall and locoregional lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients undergoing conservative surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute toxicity assessment | rate of acute toxicity according to CTCAE v4.0 scale | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate late toxicity | rate of late to according to soma lent scale | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypofractionated RT, cosmetic outcome, locoregional treatment