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NCT Number: NCT06817954

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Qiang Ding, Professor

CONTACT

[email protected]

+8613951731373

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endoscopic-assisted mastectomy and immediate breast reconstruction

Procedure

endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer

mastectomy and immediate breast reconstruction

Procedure

conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer

Primary outcomes

  1. Local recurrence free survival rate (LRFS)

    Time frame: 3 years

    Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.

  2. Regional recurrence free survival rate (RRFS)

    Time frame: 3 years

    Regional recurrence refers to the recurrence in the drainage area of ipsilateral internal mammary lymph nodes, axillary lymph nodes, or supraclavicular and infraclavicular lymph nodes.

Secondary outcomes

  1. Disease free survival (DFS)

    Time frame: 3 years

    The time from entry into the study to the first tumor recurrence or metastasis, or death of the subject for any reason.

  2. Distant metastasis free survival rate (DMFS)

    Time frame: 3 years

    Distant transfer refers to the transfer to any other location.

  3. Main complication rate

    Time frame: 3 years

    The Clavien-Dindo classification of surgical complications, including long term outcomes and short term outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Ding, Professor

CONTACT

[email protected]

13951731373

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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