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Tests treatment safety and results for Breast Cancer Patients
Official title Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation
ClinicalTrials.gov ID: NCT07037537
What this study is testing
- What it's testing
- Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study
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 70, women only
You may be able to join if
- Women aged 18 to 70 years old;
- In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor...
- Patients undergoing preventive mastectomy are not allowed to be included in the study;
- Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola...
- Clinical axillary lymph node negative (clinical physical examination and imaging suggest negative axillary lymph nodes; for suspected positive...
You likely can't join if
- Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease)...
- Double breast cancer;
- Bilateral breast reconstruction patients;
- Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
- Patients with incomplete immune function, poor control of diabetes and active smoking;
- Patients with severe breast sagging;
See the full eligibility criteria
- Women aged 18 to 70 years old;
- In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle;
- Patients undergoing preventive mastectomy are not allowed to be included in the study;
- Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall;
- Clinical axillary lymph node negative (clinical physical examination and imaging suggest negative axillary lymph nodes; for suspected positive axillary lymph nodes, fine needle aspiration or hollow needle biopsy is...
- Sentinel lymph node biopsy negative;
- Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery;
- Patients who are not suitable for breast conserving surgery or who are unwilling to undergo breast conserving surgery and plan to undergo laparoscopic assisted mastectomy with preservation of the nipple and areola, as...
- The volume of the prosthesis is less than 500cc;
- During the observation period of the study, the affected side may consider re fat injection, but symmetrical surgery is not allowed on the healthy side;
- ECOG score 0-1 points;
- New adjuvant chemotherapy patients are allowed to be enrolled;
- No smoking history or quitting smoking for at least 4 weeks;
- The researcher determines that they are able to comply with the research protocol;
- Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers to not affect the study protocol can be enrolled normally;
- After obtaining sufficient information, voluntarily participate and sign an informed consent form.
- Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;
- Double breast cancer;
- Bilateral breast reconstruction patients;
- Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
- Patients with incomplete immune function, poor control of diabetes and active smoking;
- Patients with severe breast sagging;
- Breast cup size ≥ E;
- Accept two-step breast reconstruction using dilators/prostheses, autologous breast reconstruction, and breast reconstruction performed through open surgery;
- Patients who have previously received and/or received postoperative radiotherapy for the reconstruction site or chest wall;
- Patients who plan to undergo symmetrical surgery on the healthy breast during the visit period;
- Patients with mental illnesses or abnormalities who are expected to be unable to independently complete the BREAST-Q scale;
- Pregnant and lactating patients;
- Poor compliance, unable to conduct relevant examinations and follow ups according to the trial requirements;
- Suffering from serious accompanying diseases or other comorbidities that may interfere with planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, 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.