Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Women with a strong family history of breast cancer.

Telephone interviews take place before the first counseling appointment (baseline), and 1 week, 6 months and 12 months post-notification of the individual's genetic test results. In the event that a participant chooses not to undergo genetic testing, follow-up interviews will take place 1 month, 6 months and 12 months after the initial counseling visit.

telephone interviews

Wendy Lichtenthal, Ph.D.

The purpose of this study is to learn more about women's decision to undergo prophylactic surgery. This is removal of healthy organs in order to reduce risk of cancer. This study will help us to understand what makes women decide whether or not to have this kind of surgery.

For women with a strong family history of breast/ovarian cancer, few options exist for primary prevention of these cancers other than prophylactic surgery, or surgical removal of noncancerous organs in order to prevent occurrence of the disease. The primary aim of the study is to describe the stages of intention to undergo prophylactic mastectomy and/or oophorectomy among women seeking genetic testing for inherited BRCA1 and BRCA2 mutations, and to identify factors that influence stages of intention regarding prophylactic surgery. To achieve these aims, 626 women undergoing genetic counseling and testing for inherited breast ovarian cancer risk will be assessed before their first genetic counseling session and three times (1 week, 6 months and 12 months) in the year following notification of their genetic test results.

Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations

Memorial Sloan Kettering Cancer Center

Breast Diseases

Skin Diseases

A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete.

A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).

NAC Sparing Mastectomy

Questionnaires taking about 20-30 minutes to complete.

Questionnaire

Gildy V. Babiera, MD

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.

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.

A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

M.D. Anderson Cancer Center

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

* Inframammary fold incision which is in the crease under the breast.
* Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)

  * Intraoperatively prior to mastectomy
  * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
  * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)

* Lateral radial incision
* Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)

  * Intraoperatively prior to mastectomy
  * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
  * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)

* Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.
* Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)

  * Intraoperatively prior to mastectomy
  * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
  * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)

Inframammary Fold Incision or Lateral Radial Incision

Lateral Radial Incision

Inframammary Fold Incision

Laser-assisted fluorescence angiography

Indocyanine Green

Marissa J Tenenbaum, M.D.

The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.

Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

* Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.
* The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).

-The BREAST-Q is a previously validated instrument which measures patient reported outcomes. It has several iterations including the one utilized here which is specific for implant-based breast reconstruction. Each of its 6 domains generates a Q-score from 0 (lowest) to 100 (highest). A higher number indicates a higher satisfaction or better quality of life than a lower number. Based on answers to the questions, each individual will generate a whole number score for each domain. The patient can be sampled preoperatively and postoperatively as well as over time to calculate the impact of intervention and time on this value. Q-scores are calculated for each domain, and the investigators report a mean value based on data from an entire cohort for the particular domain. Domains include evaluation of overall satisfaction with breasts, physical well being, sexual well being, as well as satisfaction with office staff, information provided, and the provider.

LifeCell

Washington University School of Medicine

Common complications occur with breast oncologic and reconstructive surgery. None of these are expected to be related to the performance of this study and will not be summarized, graded or reported as traditional adverse event reporting in an interventional oncology trial.

Inframammary Fold Incision Cohort

Lateral Radial Incision Cohort

Non-Randomized Cohort

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Study had randomized-controlled trial design with assignment to IMF or LR incision but during enrollment patients frequently withdrew from randomization due to patient/surgical oncology preference and/or preexisting scars precluding randomization.

Marissa J. Tenebaum, M.D.

Overall breast

Nipple

Inferior

Lateral

Medial

Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy

Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction

Satisfaction with Breasts (pre-op)

Satisfaction with Breasts (post-op)

Psychosocial (pre-op)

Psychosocial (post-op)

Physical chest (pre-op)

Physical chest (post-op)

Sexuality (pre-op)

Sexuality (post-op)

6 participants were not evaluable for this outcome measure in the inframammary fold incision cohort and 2 particpants were not evaluable for this outcome measure in the lateral radial incision cohort due to not completing the Breast Q score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations	NCT00579007	Breast Cancer Ovarian Cancer	telephone inter...	25 Years -	Memorial Sloan Kettering Cancer Center
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy	NCT00539227	Breast Cancer	NAC Sparing Mas... Questionnaire	-	M.D. Anderson Cancer Center
Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction	NCT01969448	Ductal Carcinom... Breast Cancer Prophylactic Ma...	Inframammary Fo... Lateral Radial ... Inframammary Fo... Laser-assisted ... Indocyanine Gre...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for prophylactic mastectomy