Status:
RECRUITING
Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Shaanxi Provincial People's Hospital
Tang-Du Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 implant...
Detailed Description
This prospective, open-label, multicenter, randomized clinical trial plans to enroll 158 patients with primary central early-stage breast cancer. Participants will be randomly assigned to two groups: ...
Eligibility Criteria
Inclusion
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- TNM stage T1-2;
- Nodal stage N0-1;
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
- Paget's disease;
- Neoadjuvant chemotherapy permitted for eligible patients;
- Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
- Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
- Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
- Participants voluntarily signed informed consent forms and completed ethics review procedures.
Exclusion
- Tumor-related characteristics
- Metastatic or bilateral breast cancer
- Inflammatory breast cancer
- Multicentric lesions
- Comorbidities/treatment history
- History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
- Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery
- 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
- Allogeneic bone marrow/solid organ transplantation history or planned
- 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)
- Reproductive status
- Pregnancy/lactation, or reproductive-aged women with:
- Positive baseline pregnancy test
- Refusal of effective contraception
- Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
- Other investigator-determined exclusionary conditions
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2030
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06938360
Start Date
February 20 2025
End Date
February 20 2030
Last Update
April 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xijing hospital
Xi'an, Shaanxi, China, 710032