Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
NCT ID: NCT03411174
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2015-04-30
2019-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HF-PBI
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.
hypofractionated partial breast irradiation
deliver 40Gy/15Fx to tumor bed areas
Interventions
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hypofractionated partial breast irradiation
deliver 40Gy/15Fx to tumor bed areas
Eligibility Criteria
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Inclusion Criteria
* Age≥ 50 years
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Negative surgical margins
* Pathologically confirmed invasive breast cancer
* A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
* Tumor bed is labeled with Titanium clips
* Received adjuvant hormonal treatment
* No adjuvant chemotherapy
* ECOG:0-1
* Written informed consent.
Exclusion Criteria
* KPS\<70
* Treated with neoadjuvant chemotherapy
* Treated or being treated with chemotherapy
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing
50 Years
85 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Jinli Ma
Associate Professor of department of radiation oncology
Principal Investigators
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Jinli Ma, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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FDRT-BC003
Identifier Type: -
Identifier Source: org_study_id
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