Assessing breast-conserving surgery for central breast cancer

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

This study is testing whether breast-conserving surgery combined with radiation is as effective and safe as total mastectomy for women with early-stage central breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06938360 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-70 with histopathologically confirmed early-stage invasive breast cancer or ductal carcinoma in situ.

Not a fit: Patients with metastatic or bilateral breast cancer, inflammatory breast cancer, or multicentric lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting breast-conserving surgery as a viable treatment option for patients with central breast cancer, potentially improving quality of life.

How similar studies have performed: Other studies have shown promising results for breast-conserving surgery in early-stage breast cancer, indicating that this approach is supported by existing evidence.

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

Where this trial is running

Xi'an, Shaanxi

• Xijing hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Ju liang J L Zhang

Conditions Breast Cancer; breast-conserving surgery