Breast CancerNCT06671249
Comparing the Safety and Cosmetic Outcomes Between Laparoscopic Versus Traditional Open Breast-conserving Surgery
A study testing Laparoscopic breast-conserving surgery and Traditional open breast-conserving surgery in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Laparoscopic breast-conserving surgery and Traditional open breast-conserving surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 25 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female over the age of 18
- Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ
- Clinical classification T1, T2 (maximum tumor diameter ≤5cm)
- Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations)
- No clinical or imaging evidence of distant metastasis
- Able and willing to sign informed consent
Who cannot join
- Tumor in the lower inner quadrant
- Tumor in multiple quadrants
- Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major
- Locally advanced breast cancer patients are undergoing neoadjuvant therapy
- Tumor in multiple quadrants
- Have been participating in other clinical trials, which may affect the participation in this trial
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- Previous history of breast cancer (patients with recurrence after ipilateral breast-conserving surgery)
- Pregnant and lactating women
- Patients with severe cardiopulmonary disease or severely impaired lung function are not suitable for surgical establishment of an air cavity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiaochen Wang
Hangzhou, Zhejiang, 31000
Xiaochen - Wang, Doctorate, +86 13958161268, wangxiaochen@zju.edu.cn
About this study
Official title: A Multicenter, Open and Prospective Randomized Controlled Trial Comparing the Safety and Cosmetic Outcomes of Laparoscopic Breast-conserving Surgery Versus Traditional Open Breast-conserving Surgery.
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Read the detailed description
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
- Conditions
- Breast Cancer
- Being tested
- Laparoscopic breast-conserving surgery, Traditional open breast-conserving surgery
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic breast-conserving surgeryProcedure or surgery
Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast
Traditional open breast-conserving surgeryProcedure or surgery
Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic breast-conserving surgery | Experimental | Subjects who is going to accept laparoscopic breast-conserving surgery. Receives: Procedure: Laparoscopic breast-conserving surgery |
| Traditional open breast-conserving surgery | Active comparator | Subjects who is going to accept traditional open breast-conserving surgery. Receives: Procedure: Traditional open breast-conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast appearance satisfaction
Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. One of the evaluation indicators is breast appearance satisfaction. Our study chooses BREAST-Q questionnaire to evaluate patients' breast appearance satisfaction.
Measured: 2 years
breast aesthetic scores
Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. Another of the evaluation indicators is breast aesthetic scores. We will invite two Plastic surgeons who did not participate in the study to judge patients' photographs, which is taken 18 months after the surgery, according to the Harris evaluation criteria.
Measured: 2 years
Secondary outcomes (3)
Complications
The study focus on intraoperative/postoperative complications between endoscopic breast-conserving and traditional open breast-conserving, including bleeding, hematoma, seroma, poor wound healing, nipple/areola necrosis, incision infection and incision dehiscence.
Measured: 1 year
Quality of Life
Whether laparoscopic breast-conserving and traditional open breast-conserving have difference in quality of life. The study measures the quality of life with the EORTC QLQ BR23 questionnaire launched by European Organization for Research and Treatment of Cancer.
Measured: 1 year
local recurrence rate
Whether laparoscopic breast-conserving and traditional open breast-conserving have difference in local recurrence rate. If local recurrence appears, record the time and location of recurrence.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start25 Oct 2024 (estimated)
- Primary completion25 May 2027 (estimated)
- Study completion25 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaochen - Wang, Doctorate, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671249
- Sponsor's protocol ID
- 2024-1251
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open and Prospective Randomized Controlled Trial Comparing the Safety and Cosmetic Outcomes of Laparoscopic Breast-conserving Surgery Versus Traditional Open Breast-conserving Surgery.
- ClinicalTrials.gov ID
- NCT06671249
- Acronym / sponsor ID
- 2024-1251
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 Oct 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Detailed description
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic breast-conserving surgery | Experimental | Procedure: Laparoscopic breast-conserving surgerySubjects who is going to accept laparoscopic breast-conserving surgery. |
| Traditional open breast-conserving surgery | Active comparator | Procedure: Traditional open breast-conserving surgerySubjects who is going to accept traditional open breast-conserving surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female over the age of 18
- Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ
- Clinical classification T1, T2 (maximum tumor diameter ≤5cm)
- Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations)
- No clinical or imaging evidence of distant metastasis
Key exclusion criteria (9 listed)
- Tumor in the lower inner quadrant
- Tumor in multiple quadrants
- Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major
- Locally advanced breast cancer patients are undergoing neoadjuvant therapy
- Tumor in multiple quadrants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic breast-conserving surgeryUse laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast | Procedure or surgery | Laparoscopic breast-conserving surgery |
| Traditional open breast-conserving surgeryTreat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery. | Procedure or surgery | Traditional open breast-conserving surgery |
Primary outcome
breast appearance satisfaction
Time frame: 2 years
Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. One of the evaluation indicators is breast appearance satisfaction. Our study chooses BREAST-Q questionnaire to evaluate patients' breast appearance satisfaction.
breast aesthetic scores
Time frame: 2 years
Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. Another of the evaluation indicators is breast aesthetic scores. We will invite two Plastic surgeons who did not participate in the study to judge patients' photographs, which is taken 18 months after the surgery, according to the Harris evaluation criteria.
3 secondary outcomes
Complications
Time frame: 1 year
Quality of Life
Time frame: 1 year
local recurrence rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaochen - Wang, Doctorate principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic breast-conserving surgery and Traditional open breast-conserving surgery in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaochen - Wang, Doctorate (+86 13958161286, wangxiaochen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast appearance satisfaction (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.