Breast CancerNCT01208974
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
A study testing Nipple-Sparing Mastectomy, Breast Reconstruction and Axillary Surgery in people with Breast Cancer and Ductal Carcinoma, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction. 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
- What is being tested?
- Nipple-Sparing Mastectomy, Breast Reconstruction and Axillary Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2010to 31 May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically confirmed in-situ or invasive breast carcinoma.
- Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm.
- Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins.
- No extensive intraductal component or patient with distant metastases.
- Patients must be > 18 years of age.
- No concomitant or history of nipple discharge or skin involvement.
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- No prior history of malignancy (less than 5 years prior to study entry), except non-melanomatous skin cancer.
- No prior history of radiation to the chest.
- No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No previous non-hormonal therapy including radiation or chemotherapy for current breast cancer.
- No patients with Paget's disease of the nipple.
- No patients with co-existing medical conditions with life expectancy < 2 years.
- No pregnant or lactating women.
- Eastern Cooperative Oncology Group (ECOG) 0 - 2.
- Signed study-specific informed consent form prior to the study entry.
Who cannot join
- Retroareolar breast cancer lesions within one cm, depth from the skin surface.
- Concomitant or history of nipple discharge or skin involvement.
- Patient with distant metastases.
- Patient with extensive intraductal carcinoma.
- Any previously irradiated ipsilateral breast cancer.
- Patients with Paget's disease of the nipple.
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- Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or dermatomyositis.
- Other malignancy, except nonmelanomatous skin cancer, less than 5 years prior to participation in this study.
- Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
- Positive surgical margins following nipple sparing mastectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Conditions
- Breast Cancer, Ductal Carcinoma
- Being tested
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery, Prophylactic Nipple-Areolar Complex RT
- Keywords
- Breast Cancer, Nipple Area Complex, Mastectomy, Radiation Therapy, Nipple-Sparing, Breast Reconstruction
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple-Sparing MastectomyProcedure or surgery
Also called NAC-sparing mastectomy, Nipple and areola complex-sparing mastectomy
Subcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1.
Breast ReconstructionProcedure or surgery
Immediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire. Performed during Week 1.
Axillary SurgeryProcedure or surgery
Also called Axillary Dissection, Sentinel Node Biopsy
Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
Prophylactic Nipple-Areolar Complex RTRadiation
Also called Prophylactic NAC Radiation Therapy
Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 MTD NAC RT | Experimental | Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows:
* Dose Level I - 10 fractions of 2.0 Gy for a total of 20 Gy
* Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy
* Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy
* Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy
Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT).
Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT. Receives: Procedure: Nipple-Sparing Mastectomy; Procedure: Breast Reconstruction; Procedure: Axillary Surgery; Radiation: Prophylactic Nipple-Areolar Complex RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Measured: Up to 13 weeks
Secondary outcomes (4)
Cosmetic Outcome
Cosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported.
Measured: 12 months
Disease-Free Survival Rate in Study Participants
Disease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death.
Measured: Up to 5 years
Overall Survival Rate in Study Participants
Overall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact..
Measured: Up to 5 years
Recurrence Rate in Study Participants
Rate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study start16 Mar 2010
- Primary completion13 Feb 2018
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Sequential
- Model description
- Phase 1 dose-escalation/de-escalation.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Takita, University of Miami
- Investigators
- Cristiane Takita, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208974
- Sponsor's protocol ID
- 20090299
- Other IDs
- SCCC-2009004
- Status last verified
- Jul 2026
- First submitted
- 22 Sep 2010
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT01208974
- Acronym / sponsor ID
- 20090299
- Conditions
- Breast Cancer, Ductal Carcinoma
- Keywords
- Breast Cancer, Nipple Area Complex, Mastectomy, Radiation Therapy, Nipple-Sparing, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 16 Mar 2010 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 dose-escalation/de-escalation.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 MTD NAC RT | Experimental | Procedure: Nipple-Sparing Mastectomy, Procedure: Breast Reconstruction, Procedure: Axillary Surgery, Radiation: Prophylactic Nipple-Areolar Complex RTParticipants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows: * Dose Level I - 10 fractions of 2.0 Gy for a total of 20 Gy * Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy * Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy * Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT). Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically confirmed in-situ or invasive breast carcinoma.
- Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm.
- Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins.
- No extensive intraductal component or patient with distant metastases.
- Patients must be > 18 years of age.
Key exclusion criteria (10 listed)
- Retroareolar breast cancer lesions within one cm, depth from the skin surface.
- Concomitant or history of nipple discharge or skin involvement.
- Patient with distant metastases.
- Patient with extensive intraductal carcinoma.
- Any previously irradiated ipsilateral breast cancer.
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 |
|---|---|---|
| Nipple-Sparing MastectomyAlso: NAC-sparing mastectomy, Nipple and areola complex-sparing mastectomySubcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1. | Procedure or surgery | Phase 1 MTD NAC RT |
| Breast ReconstructionImmediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire. Performed during Week 1. | Procedure or surgery | Phase 1 MTD NAC RT |
| Axillary SurgeryAlso: Axillary Dissection, Sentinel Node BiopsyAxillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion. | Procedure or surgery | Phase 1 MTD NAC RT |
| Prophylactic Nipple-Areolar Complex RTAlso: Prophylactic NAC Radiation TherapyProphylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8. | Radiation | Phase 1 MTD NAC RT |
Primary outcome
Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
Time frame: Up to 13 weeks
The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
4 secondary outcomes
Cosmetic Outcome
Time frame: 12 months
Disease-Free Survival Rate in Study Participants
Time frame: Up to 5 years
Overall Survival Rate in Study Participants
Time frame: Up to 5 years
Recurrence Rate in Study Participants
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Cristiane Takita, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nipple-Sparing Mastectomy, Breast Reconstruction and Axillary Surgery in people with Breast Cancer and Ductal Carcinoma, run by University of Miami at 1 site in United States.
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 14 inclusion and 10 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: finished, as of the sponsor's last update on 13 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation. (time frame: Up to 13 weeks). 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 13 Aug 2026.