Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

Study Overview
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Brief Summary
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Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.

Official Title
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Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: KPS>=60 histology confirmed invasive breast cancer received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative) surgical margins negative primary tumor ≤5cm in the largest diameter no internal mammary node or supraclavicular node metastases or distant metastasis can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy patients signed written inform consent form Exclusion Criteria: ductal carcinoma in situ prior neoadjuvant chemotherapy prior breast cancer history bilateral breast cancer pregnant or during lactation prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ active collagen vascular disease prior neoadjuvant hormone therapy immediate ipsilateral breast reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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>irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. | Radiation: radiotherapy<br>* one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.<br>|
| Active Comparator: conventional fractionation radiotherapy<br>irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week. | Radiation: radiotherapy<br>* one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-breast recurrence rate | evidence of ipsilateral breast local recurrence confirmed by histology | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regional node recurrence rate | ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology. | 5 year | 
| disease-free survival | locoregional relapse, distant relapse, death | 5 year | 
| overall survival | any death | 5 year | 
| acute toxicity | radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria | 6 months | 
| late complication | breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction | 3 -10 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer patients, breast conservation surgery, hypofractionated radiotherapy