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The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HF-PBI | Experimental | Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated partial breast irradiation | Radiation | deliver 40Gy/15Fx to tumor bed areas |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of breast cosmetic outcome | The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system | Baseline, and three years after the completion of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute radiation-induced toxicity assessed by CTCAE v4.0 | acute toxicity related to skin and lung | 3weeks, 5weeks,1 and 3 months after treatment beginning |
| Late complications | Complications related to radiation treatment after more than 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinli Ma, MD,PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39890895 | Derived | Zhang X, Wang X, Xu Z, Chu Y, Chen X, Zhang L, Meng J, Shi W, Yang Z, Mei X, Yu X, Zhang Z, Guo X, Mo M, Liu G, Wu J, Shao Z, Ma J. Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial. Sci Rep. 2025 Jan 31;15(1):3869. doi: 10.1038/s41598-025-88600-5. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 3 years |
| Ipsilateral breast tumor recurrence rate | The pathological confirmed tumor recurrence in the same breast | 5 years |
| Local-regional recurrence | Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain. | 5 years |
| Disease free survival | The interval from diagnosis to disease recurrence or death or last visit. | 5 years |
| Overall survival | The interval from diagnosis to death or last visit | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |