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This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.
Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.
Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.
Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: High-risk group | Active Comparator | Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:
Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:
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| Arm 2: Low-risk group | Active Comparator | Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria: â‘ Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease. â‘¡ Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-breast irradiation and tumor bed boost | Radiation | Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions |
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| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate | Ipsilateral breast recurrence rate | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival rate | Disease-free survival rate | Five years |
| Radiation-related adverse events | Adverse events | Five years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Lian Wang, MD | Contact | 8610-87788803 | wangsl@cicams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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| Partial-breast irradiation | Radiation | Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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