Breast CancerAPRESERVE-1NCT07544134
Areola Preservation in NSM With Nipple Involvement
A study testing Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction in people with Breast Cancer and Ductal Carcinoma In Situ, DCIS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Background: During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma In Situ, DCIS, Invasive Breast Carcinoma
- What is being tested?
- Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 15 Jan 2030
- 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, age ≥ 18 years.
- Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).
- Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).
- Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.
- Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.
- ECOG performance status 0-1.
- Willing and voluntarily provide written informed consent.
Who cannot join
- Clinical or radiological suspicion of areola or skin involvement.
- Inflammatory breast cancer.
- Pregnancy or lactation.
- Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.
- Severe uncontrolled comorbidities with a life expectancy of less than 5 years.
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Oncologic Safety and Aesthetic Outcomes of Areola Preservation With Simultaneous Nipple Reconstruction in Nipple-Sparing Mastectomy With Intraoperative Nipple Involvement: A Single-Center, Prospective, Exploratory Study
Background:
During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.
Read more
Purpose:
This is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.
Study Plan:
This is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:
The nipple is removed.
A small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.
A new nipple is created during the same operation using a local skin flap technique (purse-string suture).
All patients will have immediate breast reconstruction.
We plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications.
What We Will Measure (Exploratory Endpoints):
Safety \& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis).
Early Effectiveness: The rate of cancer returning in the breast/chest wall area within 3 years (local recurrence).
Patient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery.
Why This Study is Important:
This is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.
Read the detailed description
This study evaluates the oncological safety and aesthetic outcomes of areola preservation with simultaneous nipple reconstruction in breast cancer patients undergoing nipple-sparing mastectomy who have nipple involvement but negative areolar margins on intraoperative frozen section. The intervention involves removing the nipple while preserving the areolar skin flap and performing immediate nipple reconstruction using a purse-string suture technique. This single-arm, prospective, exploratory study will enroll 45 patients. Primary outcome is technical success rate; secondary outcomes include 3-year local recurrence, complications, BREAST-Q scores, and nipple projection maintenance.
- Being tested
- Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction
- Keywords
- Breast Cancer, Nipple Sparing Mastectomy, NSM, Nipple Areola Complex, Nipple Reconstruction
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple ReconstructionProcedure or surgery
This is a combined surgical procedure for patients with intraoperative nipple involvement during nipple-sparing mastectomy. After resection of the involved nipple, a full-thickness peri-areolar tissue margin is harvested for a second intraoperative frozen section. If the margin is negative for carcinoma, the areola skin is preserved. An immediate nipple reconstruction is then performed using a local skin flap technique (e.g., purse-string suture). This is followed by standard immediate breast reconstruction (implant-based or autologous).
| Study group | Role | What they receive |
|---|---|---|
| Areola Preservation & Nipple Reconstruction Group | Experimental | Patients with intraoperatively confirmed nipple involvement during nipple-sparing mastectomy, who receive areola-preserving surgery (pending negative second frozen section of the peri-areolar margin) combined with immediate nipple reconstruction via a local flap technique (e.g., purse-string suture), followed by immediate breast reconstruction. Receives: Procedure: Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence Rate
The incidence of local recurrence in the ipsilateral chest wall/skin or residual breast tissue, assessed by clinical examination and imaging (breast ultrasound and/or MRI), with pathological confirmation for suspected cases.
Measured: 3 years post-surgery
Secondary outcomes (3)
Rate of Successful Areola Preservation
The proportion of patients in whom the areola is successfully preserved, defined as having a negative result on the second intraoperative frozen section of the peri-areolar margin.
Measured: Intraoperative
Incidence of Postoperative Complications
The rate of surgical complications, including but not limited to areolar skin necrosis (partial/full), infection, seroma, hematoma, and implant loss/failure.
Measured: Within 90 days post-surgery
Change in Patient-Reported Satisfaction and Well-being
Change in scores from baseline as measured by the validated BREAST-Q questionnaire modules (Satisfaction with Breasts, Psychosocial, Sexual, and Physical Well-being).
Measured: Baseline, 6, 12, 24, and 36 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2030 (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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, prospective, exploratory study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke Wang, MD, Principal investigator, Department of Breast Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544134
- Sponsor's protocol ID
- APRESERVE-2025-1471
- Acronym
- APRESERVE-1
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is a single-center exploratory trial. Data sharing is not planned because the sample size is small (n=45) and the study is primarily designed to generate preliminary parameter estimates for future multi-center trials.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Safety and Aesthetic Outcomes of Areola Preservation With Simultaneous Nipple Reconstruction in Nipple-Sparing Mastectomy With Intraoperative Nipple Involvement: A Single-Center, Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT07544134
- Acronym / sponsor ID
- APRESERVE-1 / APRESERVE-2025-1471
- Keywords
- Breast Cancer, Nipple Sparing Mastectomy, NSM, Nipple Areola Complex, Nipple Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 22 Apr 2026 (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.
Background:
During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.
Purpose:
This is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.
Study Plan:
This is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:
The nipple is removed.
A small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.
A new nipple is created during the same operation using a local skin flap technique (purse-string suture).
All patients will have immediate breast reconstruction.
We plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications.
What We Will Measure (Exploratory Endpoints):
Safety \& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis).
Early Effectiveness: The rate of cancer returning in the breast/chest wall area within 3 years (local recurrence).
Patient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery.
Why This Study is Important:
This is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.
Detailed description
This study evaluates the oncological safety and aesthetic outcomes of areola preservation with simultaneous nipple reconstruction in breast cancer patients undergoing nipple-sparing mastectomy who have nipple involvement but negative areolar margins on intraoperative frozen section. The intervention involves removing the nipple while preserving the areolar skin flap and performing immediate nipple reconstruction using a purse-string suture technique. This single-arm, prospective, exploratory study will enroll 45 patients. Primary outcome is technical success rate; secondary outcomes include 3-year local recurrence, complications, BREAST-Q scores, and nipple projection maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective, exploratory study
| Arm | Type | Receives |
|---|---|---|
| Areola Preservation & Nipple Reconstruction Group | Experimental | Procedure: Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple ReconstructionPatients with intraoperatively confirmed nipple involvement during nipple-sparing mastectomy, who receive areola-preserving surgery (pending negative second frozen section of the peri-areolar margin) combined with immediate nipple reconstruction via a local flap technique (e.g., purse-string suture), followed by immediate breast reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, age ≥ 18 years.
- Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).
- Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).
- Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.
- Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.
Key exclusion criteria (5 listed)
- Clinical or radiological suspicion of areola or skin involvement.
- Inflammatory breast cancer.
- Pregnancy or lactation.
- Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.
- Severe uncontrolled comorbidities with a life expectancy of less than 5 years.
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 |
|---|---|---|
| Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple ReconstructionThis is a combined surgical procedure for patients with intraoperative nipple involvement during nipple-sparing mastectomy. After resection of the involved nipple, a full-thickness peri-areolar tissue margin is harvested for a second intraoperative frozen section. If the margin is negative for carcinoma, the areola skin is preserved. An immediate nipple reconstruction is then performed using a local skin flap technique (e.g., purse-string suture). This is followed by standard immediate breast reconstruction (implant-based or autologous). | Procedure or surgery | Areola Preservation & Nipple Reconstruction Group |
Primary outcome
Local Recurrence Rate
Time frame: 3 years post-surgery
The incidence of local recurrence in the ipsilateral chest wall/skin or residual breast tissue, assessed by clinical examination and imaging (breast ultrasound and/or MRI), with pathological confirmation for suspected cases.
3 secondary outcomes
Rate of Successful Areola Preservation
Time frame: Intraoperative
Incidence of Postoperative Complications
Time frame: Within 90 days post-surgery
Change in Patient-Reported Satisfaction and Well-being
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
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 22 Apr 2026.
- Individual participant dataSharing planned: No. The study is a single-center exploratory trial. Data sharing is not planned because the sample size is small (n=45) and the study is primarily designed to generate preliminary parameter estimates for future multi-center trials.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Ke Wang, MD principal investigator
Department of Breast Surgery, The Second Affiliated Hospital of 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 Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction in people with Breast Cancer and Ductal Carcinoma In Situ, DCIS, 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 7 inclusion and 5 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 22 Apr 2026. 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 Jingxin Jiang, MD (+86-1356711447, blwangke@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence Rate (time frame: 3 years post-surgery). 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 22 Apr 2026.