Clinical trial · Interventional
Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins). The primary endpoint was local recurrence rate, with secondary endpoints including disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast-conserving surgery combined with radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction)
- description
- Prosthetic implantation or autologous tissue transfer reconstruction was permitted
- type
- EXPERIMENTAL
- label
- breast-conserving surgery combined with radiotherapy
- description
- nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins
- interventionNames
- Procedure: breast-conserving surgery combined with radiotherapy
Primary outcomes (1)
- measure
- Local recurrence rate (LRR)
- timeFrame
- From enrollment to 3 years later or death
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
1. Female patients aged 18-70 years with primary breast cancer;
2. Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
* TNM stage T1-2;
* Nodal stage N0-1;
3. Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
4. Paget's disease;
5. Neoadjuvant chemotherapy permitted for eligible patients;
6. Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
7. Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
8. Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
9. Participants voluntarily signed informed consent forms and completed ethics review procedures.
Exclusion Criteria:
1. Tumor-related characteristics
1. Metastatic or bilateral breast cancer
2. Inflammatory breast cancer
3. Multicentric lesions
2. Comorbidities/treatment history
1. History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
2. Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery
3. Active infections/immune disorders:
HIV/AIDS Viral hepatitis (HBV-DNA≥500 IU/ml; HCV antibody-positive with detectable HCV-RNA) Autoimmune hepatitis HBV/HCV coinfection
4. Allogeneic bone marrow/solid organ transplantation history or planned
5. Cardiovascular diseases:
* Heart failure or LVEF\<50%
* Uncontrolled arrhythmias (resting heart rate\>100 bpm, ventricular tachycardia, Mobitz II/third-degree AV block)
* Angina requiring antianginal drugs
* Clinically significant valvulopathy
* Transmural myocardial infarction on ECG
* Uncontrolled hypertension (SBP\>180 mmHg and/or DBP\>100 mmHg)
3. Reproductive status
Pregnancy/lactation, or reproductive-aged women with:
* Positive baseline pregnancy test
* Refusal of effective contraception
4. Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
5. Other investigator-determined exclusionary conditionsReferences
Publications (0)
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