Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT06938360

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

Led by Xijing Hospital · Updated on 2025-04-22

158

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

X

Xijing Hospital

Lead Sponsor

S

Shaanxi Provincial People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 70 years with primary breast cancer
  • Histopathologically confirmed invasive breast cancer meeting ASCO/CAP guidelines with TNM stage T1-2 and nodal stage N0-1
  • Ductal carcinoma in situ with maximum tumor diameter less than 3 cm
  • Paget's disease
  • Eligible for neoadjuvant chemotherapy
  • Unicentric lesion confirmed by breast ultrasound, mammography, and MRI
  • Nipple-areolar complex resection required for confirmed nipple involvement
  • Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy
  • Signed informed consent and completed ethics review procedures
Not Eligible

You will not qualify if you...

  • Metastatic or bilateral breast cancer
  • Inflammatory breast cancer
  • Multicentric lesions
  • History of other malignancies except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
  • Prior systemic or local anticancer therapy
  • Major non-breast surgery within 4 weeks before enrollment without full recovery
  • Active infections or immune disorders including HIV/AIDS, viral hepatitis with high HBV-DNA or detectable HCV-RNA, autoimmune hepatitis, or HBV/HCV coinfection
  • History or planned allogeneic bone marrow or solid organ transplantation
  • Cardiovascular diseases including heart failure or LVEF less than 50%, uncontrolled arrhythmias, angina requiring drugs, significant valvulopathy, myocardial infarction on ECG, uncontrolled hypertension
  • Pregnancy, lactation, or positive baseline pregnancy test
  • Refusal of effective contraception if of reproductive age
  • Epilepsy, dementia, psychoactive substance abuse, or alcoholism
  • Other investigator-determined exclusionary conditions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Xijing hospital

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

J

Ju liang J L Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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