Assessing breast-conserving surgery for central breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves 158 female patients with primary central early-stage breast cancer, who are randomly assigned to either undergo total mastectomy or breast-conserving surgery combined with radiotherapy. The study aims to evaluate the local recurrence rate as the primary endpoint, while also assessing disease-free survival, overall survival, patient-reported outcomes, and surgery-related complications as secondary endpoints. Participants will receive standardized adjuvant therapy based on established guidelines, and those eligible may also receive neoadjuvant chemotherapy. The trial is designed to provide insights into the efficacy and safety of breast-conserving surgery compared to total mastectomy.

Why it matters

Who can join: the full rules

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

Where it's running

• Xijing hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Ju liang J L Zhang
• Email: vascularzhang@163.com
• Phone: 029-84775271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.