Breast CancerPhase 3NCT01412788
Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
A Phase 3 study testing peri-areolar incision and traditional incision in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- peri-areolar incision and traditional incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients desire for breast conserving surgery;
- fulfills criteria for breast conserving surgery;
- the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola;
- patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included;
Who cannot join
- patients not suitable for breast conserving surgery;
- skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;
- male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure;
- Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Sun Qiang, Master, 86-010-88068936, sunq@medmail.com.cn
Shen Songjie, Doctor, 86-010-88068936, pumcssj@163.com
About this study
Official title: Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials.
This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
Read the detailed description
The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.
- Conditions
- Breast Cancer
- Being tested
- peri-areolar incision, traditional incision
- Keywords
- breast cancer, Breast Conserving Surgery, Peri-areolar Incision
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-areolar incisionProcedure or surgery
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
traditional incisionProcedure or surgery
Traditional incision above tumor was used to carry out breast-conserving surgery.
| Study group | Role | What they receive |
|---|---|---|
| peri-areolar incision | Experimental | Peri-areolar incision was used to carry out lumpectomy Receives: Procedure: peri-areolar incision |
| traditional incision | Active comparator | traditional incision above tumor was used to carry out lumpectomy Receives: Procedure: traditional incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
local recurrence, regional recurrence, distant metastasis, death
Measured: 5 years
Secondary outcomes (2)
aesthetic outcomes
aesthetic score and QOL score
Measured: two weeks, half a year and one year
cost
operation time for the surgery, hospital stay days, costs
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startJan 2007
- Primary completionJan 2013 (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 Peking Union Medical College HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sun Qiang, Master, Study chair, PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412788
- Sponsor's protocol ID
- PUMCH- BCS
- Status last verified
- Aug 2011
- First submitted
- 7 Aug 2011
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
- ClinicalTrials.gov ID
- NCT01412788
- Acronym / sponsor ID
- PUMCH- BCS
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Breast Conserving Surgery, Peri-areolar Incision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2013 (estimated)
- First posted
- 9 Aug 2011 (estimated)
- 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.
Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials.
This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
Detailed description
The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peri-areolar incision | Experimental | Procedure: peri-areolar incisionPeri-areolar incision was used to carry out lumpectomy |
| traditional incision | Active comparator | Procedure: traditional incisiontraditional incision above tumor was used to carry out lumpectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients desire for breast conserving surgery;
- fulfills criteria for breast conserving surgery;
- the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola;
- patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included;
Key exclusion criteria (4 listed)
- patients not suitable for breast conserving surgery;
- skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;
- male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure;
- Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.
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 |
|---|---|---|
| peri-areolar incisionperi-areolar incision was used to carry out lumpectomy in breast-conserving surgery. | Procedure or surgery | peri-areolar incision |
| traditional incisionTraditional incision above tumor was used to carry out breast-conserving surgery. | Procedure or surgery | traditional incision |
Primary outcome
event free survival
Time frame: 5 years
local recurrence, regional recurrence, distant metastasis, death
2 secondary outcomes
aesthetic outcomes
Time frame: two weeks, half a year and one year
cost
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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. This study is not recruiting at the moment.
Sun Qiang, Master study chair
PUMCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peri-areolar incision and traditional incision in people with Breast Cancer, run by Peking Union Medical College Hospital 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Qiang, Master (86-010-88068936, sunq@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event free survival (time frame: 5 years). 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 9 Aug 2011.