Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
NCT ID: NCT06375798
Last Updated: 2025-09-15
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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RECRUITING
620 participants
OBSERVATIONAL
2020-11-19
2026-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IORT group
The IORT group received intraoperative radiotherapy with a regimen of 50-KV-X 20Gy/1f.If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.
radiotherapy
If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.
WBI group
WBI group received whole milk external irradiation with a regimen of 50Gy/25f.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously.
radiotherapy
If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.
Interventions
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radiotherapy
If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.
Eligibility Criteria
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Inclusion Criteria
2. Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0；
3. Patients who are willing to preserve milk and intend to undergo breast-conserving surgery；
4. If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm；
5. ER≥ 30% and PR≥ 1%, HER2 negative；
6. Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up.
Exclusion Criteria
2. Previous ipsilateral breast cancer and/or prior chest wall radiation therapy；
3. There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest；
4. The investigators did not consider the patient suitable for participation in any other conditions of the study.
55 Years
FEMALE
Yes
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Responsible Party
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Cuizhi GENG
professor
Principal Investigators
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cuizhi GENG, archiater
Role: STUDY_DIRECTOR
Hebei Medical University Fourth Hospital
Locations
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020137
Identifier Type: -
Identifier Source: org_study_id
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