NCT06938360 Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
| NCT ID | NCT06938360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2028-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 158 participants in total. It began in 2025-02-20 with a primary completion date of 2028-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 conditions
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06938360 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938360 currently recruiting?
Yes, NCT06938360 is actively recruiting participants. Contact the research team at vascularzhang@163.com for enrollment information.
Where is the NCT06938360 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06938360 clinical trial?
NCT06938360 is sponsored by Xijing Hospital. The trial plans to enroll 158 participants.
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