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Tests treatment safety and results for Breast Cancer
Official title To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
ClinicalTrials.gov ID: NCT06817954
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal...
- Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor...
- 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...
- Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.