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Recruiting NCT06817954

To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoscopic-assisted mastectomy and immediate breast reconstruction, mastectomy and immediate breast reconstruction.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)

Overview

The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.

Interventions

  • Procedure endoscopic-assisted mastectomy and immediate breast reconstruction
    endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
  • Procedure mastectomy and immediate breast reconstruction
    conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer

Primary outcome measures

  • Local recurrence free survival rate (LRFS) [Time frame: 3 years]
  • Regional recurrence free survival rate (RRFS) [Time frame: 3 years]
Secondary outcome measures (3)
  • Disease free survival (DFS) [Time frame: 3 years]
  • Distant metastasis free survival rate (DMFS) [Time frame: 3 years]
  • Main complication rate [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
  • Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
  • There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
  • There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
  • Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
  • Preoperative clinical manifestations and imaging data showed no distant metastasis;
  • No history of breast cancer or other serious underlying diseases in the past;
  • Karnofsky performance status score ≥ 70;
  • Eastern Cooperative Oncology Group score ≤ 2 ;
  • The surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction;
  • Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;
  • No swallowing difficulties; No shoulder joint movement disorders;
  • Complete clinical data.

Exclusion criteria

  • Male breast cancer or inflammatory breast cancer;
  • Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
  • The clinical data is basically incomplete;
  • Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
  • Bilateral breast cancer surgery;
  • Other surgical methods;
  • Preoperative distant metastasis or supraclavicular lymph node dissection;
  • Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
  • The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
  • Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06817954 · BC-MCWIBR-20250205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗