A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Detailed Description
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Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Official Title
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A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: hypofractionation radiotherapy
* Radiation: conventional fractionation radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ipsilateral histologically confirmed invasive breast cancer Undergone total mastectomy and axillary dissection T3-4,or >=4 positive axillary lymph nodes Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation Written,informed consent cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy no supraclavicular or internal mammary nodes metastases no distant metastases enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy. enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy. Exclusion Criteria: Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region Previous or concurrent malignant other than non-melanomatous skin cancer Unable or unwilling to give informed consent bilateral breast cancer immediate or delayed ipsilateral breast cancer reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: hypofractionation radiotherapy<br>breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region | Radiation: hypofractionation radiotherapy<br>* radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region<br>* Other names: radiotherapy;|
| Active Comparator: conventional fractionation radiotherapy<br>breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region | Radiation: conventional fractionation radiotherapy<br>* 50Gy/25/f/5w<br>* Other names: radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional control rate | ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | any death | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, mastectomy, radiotherapy, fractionation