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Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial

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About this study

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.

Condition
Breast Cancer
Tested
breast-conserving surgery combined with radiotherapy
Sponsor
Xijing Hospital

Who can join

Age
18 to 70 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Eligible sex: Female
  • Study condition: Breast Cancer
  • 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 23

  • 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

Where

1 site, 1 recruiting

Xijing hospital

Xi'an, Shaanxi, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.