Post Mastectomy Hypofractionated 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 hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. It's 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 divided into two groups: conventional fractionated (CF) radiotherapy of 50 Gray (GY) in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region, and hypofractionated (HF) radiotherapy of 43.5 Gray (GY) 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 Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Hypofractionated radiotherapy
* Radiation: Conventional fractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes. Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation. Written informed concent. C T3-4 , or C N2, 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 did't receive neoadjuvant therapy. Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did'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 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
Interventional Model Description: Assignment Masking: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group (1)<br>Hypofractionated radiotherapy women with T3-4 and /or 4 or more axillary nodes involvement post mastectomy. Hypofractionated radiotherapy 43,5 GY/15 fractions (f) /3w. to chest wall and supraclavicular nodal region. | Radiation: Hypofractionated radiotherapy<br>* Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region. .<br>|
| Active Comparator: group(2)<br>Conventional fractionated radiotherapy breast cancer women with T3-4 and/ or 4 or more axillary nodes involvement post mastectomy. Conventional fractionated radiotherapy 50 Gray(GY)/25 fractions (f)/5w to chest wall and supraclavicular nodal region. | Radiation: Conventional fractionated radiotherapy<br>* 50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region<br>|

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. | 60 female patients with high risk post mastectomy breast cancer will divided randomly into two equal groups One group will received hypofractionated (HF) regimen of postoperative radiotherapy, and group two will receive conventional fractionated (CF) regimen of postoperative local radiotherapy. in high risk breast cancer , comparison between the two treated groups. | two years | 
| Frequency of local recurrence. | Comparison between the treatment groups. | one year | 
| Toxicity outcome/ side affects that may occur with breast radiation therapy. | Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency. | two years | 
| Histopathologic grades of the tumor. | Comparison between the two treatment groups. | one year | 
| Pathological tumour size (pT stage classification) | cT 3-4 | one year | 
| Pathological node status (pN stage classification) (cN) | cN 2 (4 or more positive axillary lymph nodes. | one year | 
| Frequency of distant metastasis | Compare two treatment groups regarding the frequency of distant metastasis. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival. | Any deaths | two years |