Breast CancerNCT00539227
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- NAC Sparing Mastectomy and Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2013
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with breast cancer.
Who may be able to join
- Patients desiring prophylactic mastectomy with immediate reconstruction
- Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction
- Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam
- Patients must sign an informed consent and be registered before the procedure is performed
Who cannot join
- Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge
- Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of the NAC
- Patients with Paget's disease of the nipple
- Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin
- Patients with history of prior surgery involving a periareolar incision
- Patients desiring a concomitant ipsilateral reduction mammoplasty at time of mastectomy
Show all 11Show fewer
- Patients with macromastia as defined by the plastic surgeon
- Patients with a body mass index (BMI) greater than 40 kg/m2
- Patients who actively smoke
- Patients with known collagen vascular disease
- Patients with prior ipsilateral chest wall irradiation less than 12 months from their time of surgery
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.
Read the detailed description
Operative Procedure:
You will have a skin-sparing mastectomy performed with preservation of the NAC. During surgery, the tissue will be tested while you are still under general anesthesia.
The NAC may be removed completely during the surgery if malignant cells are found during the testing done during the surgery or if suspicious cells that are not clearly benign cells are found. This will be up to your doctor. The NAC may also be removed surgically if the primary tumor is found to be located less than an inch from the border of the NAC, or you are found to have breast cancer with multiple "center" sites. The nipple can also be removed by itself, with the areola spared (this is called "areolar-sparing mastectomy") if your doctor is worried about its blood supply. These decisions will be made by your pathologist and treating surgeon.
You will then undergo immediate reconstruction, with either your own tissue, prosthetic tissue, or a combination of the two. This is up to your plastic surgeon. You will have met with your plastic surgeon before surgery to discuss the best reconstructive method for you, and you will be given an informed consent to sign at that time with details about the method you decide to use.
The breast tissue under the NAC will be biopsied and tested after your surgery. After that tissue has been tested, a second surgery may be needed if cancer cells are found, the tumor is too close to the NAC, or it has more than 1 "center" site. You will have the whole NAC removed in a separate operation. The place where the NAC was removed will be repaired by a plastic surgeon, who will choose the best method to get an acceptable cosmetic result. This may involve one or more extra surgeries, and you will be given separate informed consent documents to sign for each surgery.
Follow-up and Questionnaires:
If you agree to take part in this study, 4 sensory tests will be conducted on both breasts using a variety of hand-held devices. These tests are painless and will be performed at regularly scheduled follow-up visits in clinic. They will measure nipple and areolar sensitivity, as well as nipple erectibility. The tests will involve the placement of fibers of various thicknesses and blunt metal probes on the skin of your nipple and areola. All tests will be performed once before the surgery and then at about 3 months, 6 months, and 1 year after surgery, at your follow-up clinic visits.
Your breasts will be photographed at your 6-month and 1-year follow-up visits after surgery. At these visits, you will look at those photographs to decide how satisfied you are with how the breasts look. Two (2) plastic surgeons not directly involved in your surgery will also study those photographs by themselves and fill out a similar questionnaire rating their impression of the results of your plastic surgery. These results will not be made available to you. You will also complete 2 quality-of-life questionnaires within 1 month of your surgery, and then at 3 months, 6 months, 1 year, 2 years, and 5 years after surgery (+/- 1 month). The questionnaires will ask questions about nipple sensation, cosmetic outcomes, complications, and your quality of life. The questionnaires will take about 30 minutes to complete.
Length of Study:
You will remain on study for up to 5 years.
This is an investigational study. Up to 37 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- NAC Sparing Mastectomy, Questionnaire
- Keywords
- Breast Cancer, Nipple-Areolar Complex, Mastectomy, Prophylactic mastectomy, Immediate reconstruction, Reconstructive surgery, Questionnaire, Survey, NAC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAC Sparing MastectomyProcedure or surgery
A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).
QuestionnaireBehavioural
Also called Survey
Questionnaires taking about 20-30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| NAC Sparing Mastectomy | A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete. Receives: Procedure: NAC Sparing Mastectomy; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple Sensation Evaluation (following NAC sparing mastectomy)
Measured: Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2013
- Study completionJul 2013
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 M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gildy V. Babiera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539227
- Sponsor's protocol ID
- 2007-0194
- Status last verified
- Aug 2013
- First submitted
- 2 Oct 2007
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
- ClinicalTrials.gov ID
- NCT00539227
- Acronym / sponsor ID
- 2007-0194
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Nipple-Areolar Complex, Mastectomy, Prophylactic mastectomy, Immediate reconstruction, Reconstructive surgery, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Oct 2007 (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.
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.
Detailed description
Operative Procedure:
You will have a skin-sparing mastectomy performed with preservation of the NAC. During surgery, the tissue will be tested while you are still under general anesthesia.
The NAC may be removed completely during the surgery if malignant cells are found during the testing done during the surgery or if suspicious cells that are not clearly benign cells are found. This will be up to your doctor. The NAC may also be removed surgically if the primary tumor is found to be located less than an inch from the border of the NAC, or you are found to have breast cancer with multiple "center" sites. The nipple can also be removed by itself, with the areola spared (this is called "areolar-sparing mastectomy") if your doctor is worried about its blood supply. These decisions will be made by your pathologist and treating surgeon.
You will then undergo immediate reconstruction, with either your own tissue, prosthetic tissue, or a combination of the two. This is up to your plastic surgeon. You will have met with your plastic surgeon before surgery to discuss the best reconstructive method for you, and you will be given an informed consent to sign at that time with details about the method you decide to use.
The breast tissue under the NAC will be biopsied and tested after your surgery. After that tissue has been tested, a second surgery may be needed if cancer cells are found, the tumor is too close to the NAC, or it has more than 1 "center" site. You will have the whole NAC removed in a separate operation. The place where the NAC was removed will be repaired by a plastic surgeon, who will choose the best method to get an acceptable cosmetic result. This may involve one or more extra surgeries, and you will be given separate informed consent documents to sign for each surgery.
Follow-up and Questionnaires:
If you agree to take part in this study, 4 sensory tests will be conducted on both breasts using a variety of hand-held devices. These tests are painless and will be performed at regularly scheduled follow-up visits in clinic. They will measure nipple and areolar sensitivity, as well as nipple erectibility. The tests will involve the placement of fibers of various thicknesses and blunt metal probes on the skin of your nipple and areola. All tests will be performed once before the surgery and then at about 3 months, 6 months, and 1 year after surgery, at your follow-up clinic visits.
Your breasts will be photographed at your 6-month and 1-year follow-up visits after surgery. At these visits, you will look at those photographs to decide how satisfied you are with how the breasts look. Two (2) plastic surgeons not directly involved in your surgery will also study those photographs by themselves and fill out a similar questionnaire rating their impression of the results of your plastic surgery. These results will not be made available to you. You will also complete 2 quality-of-life questionnaires within 1 month of your surgery, and then at 3 months, 6 months, 1 year, 2 years, and 5 years after surgery (+/- 1 month). The questionnaires will ask questions about nipple sensation, cosmetic outcomes, complications, and your quality of life. The questionnaires will take about 30 minutes to complete.
Length of Study:
You will remain on study for up to 5 years.
This is an investigational study. Up to 37 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAC Sparing Mastectomy | – | Procedure: NAC Sparing Mastectomy, Behavioral: QuestionnaireA skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with breast cancer.
Key inclusion criteria (4 listed)
- Patients desiring prophylactic mastectomy with immediate reconstruction
- Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction
- Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam
- Patients must sign an informed consent and be registered before the procedure is performed
Key exclusion criteria (11 listed)
- Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge
- Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of the NAC
- Patients with Paget's disease of the nipple
- Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin
- Patients with history of prior surgery involving a periareolar incision
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 |
|---|---|---|
| NAC Sparing MastectomyA skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). | Procedure or surgery | NAC Sparing Mastectomy |
| QuestionnaireAlso: SurveyQuestionnaires taking about 20-30 minutes to complete. | Behavioural | NAC Sparing Mastectomy |
Primary outcome
Nipple Sensation Evaluation (following NAC sparing mastectomy)
Time frame: Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- The University of Texas (UT) MD Anderson Cancer Center official websiteLink provided by the sponsor.
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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.
Gildy V. Babiera, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center 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 4 inclusion and 11 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 26 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nipple Sensation Evaluation (following NAC sparing mastectomy) (time frame: Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)). 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 26 Aug 2013.