Nipple Delay Prior to Nipple Sparing Mastectomy: A Pilot RCT

NCT02526719 | Withdrawn

• 1 other identifier: UHN14-7891
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to reconstruct a breast mound with preservation a patient's natural skin envelope. Preservation of the nipple and areola complex during mastectomy and breast reconstruction is associated with improved quality of life and a better cosmetic result. However, this surgical technique relies on tenuous blood supply to maintain the nipple and areola. Therefore a certain proportion of women will actually lose their preserved nipple-areolar complex due to vascular insufficiency. Furthermore, some women may find out after a nipple-sparing mastectomy that cancer had invaded the nipple-areolar complex, and would require another operation to completely remove the cancer. Despite these devastating complications, there have been no controlled studies to investigate mechanisms to reduce the chance of their occurrence. Our research study will use a pre-operative minor procedure to enhance blood flow to the nipple-areola complex prior to standard nipple sparing mastectomy among eligible women undergoing mastectomy for breast cancer or risk reduction. A secondary objective is to test how many women actually have active cancer in their nipple at the time of this minor surgical procedure, prior to standard NSM. The investigators hypothesize that our innovative and novel nipple-delay procedure will reduce the risk of loss of the nipple due to vascular insufficiency and may be of benefit to identify the small proportion of women with nipple-areola complex involvement, in order to optimize the ultimate cancer ablation. For this study the investigators propose to undertake a Pilot RCT as the first step in the evaluation of a delay procedure prior to NSM, and the results will be used to determine the feasibility and inform the optimal design for a definitive RCT. This study question has the potential to set a new standard of care in the management of women seeking NSM for the management of their breast cancer.

Conditions

Breast Cancer

Keywords

bilateral prophylactic mastectomies; immediate breast reconstruction; nipple sparing; BRCA1 Protein

Outcome Measures

Primary Outcomes (1)

• Nipple-areolar complex (NAC)

  We will compare the proportion of patients in each group that develop NAC necrosis, defined as necrosis requiring local wound care with dressings or surgical debridement. The proportion of patients in each group that develop total (\> 75% of NAC) and partial (25 to 75% of NAC) NAC necrosis will be measured at 2 week and 4 weeks after the definitive NSM procedure by the treating plastic surgeon and surgical oncologist, respectively. We will take photographs to provide objective documentation.

  NAC necrosis will be measured at 2 week and 4 weeks after the definitive NSM procedure by the treating plastic surgeon and surgical oncologist, respectively.

Study Arms (2)

Standard Nipple-Sparing Mastectomy

NO INTERVENTION

Patients in the control group will receive usual care. The surgical oncologist will perform the NSM and sentinel lymph node biopsy if indicated (active breast cancer or DCIS). We will submit a nipple core biopsy and a 1cm thick biopsy of immediately retro-areolar ductal tissue for permanent section pathology for control patients, and all patients will have the mastectomy specimen submitted for permanent section pathology. Under the same general anaesthesia, the plastic surgeon will perform the IBR (2-stage tissue expander to implant or 1-stage direct to implant). Patients who later have a positive nipple core and retro-areolar biopsy will have a discussion with the surgical oncologist regarding the need for revision breast surgery to excise the NAC, as is current practice.

Nipple Delay Intervention

EXPERIMENTAL

Patients in the experimental group will have a nipple-delay intervention in addition to usual care. The nipple delay procedure will be performed by the plastic surgeon in the minor clinic procedure room under local anaesthetic 7 - 21 days prior definitive NSM with IBR. The skin flap will be elevated in the plane of the prophylactic mastectomy beneath the NAC. A nipple core biopsy and a 1cm thick biopsy of immediately subareolar ductal tissue will be submitted for permanent section pathology. This approach is consistent with the previous case series of nipple delay for NSM and approved by the multi-disciplinary breast cancer team at our institutions. Patients that have a positive nipple core or sub-areolar biopsy will have the NAC removed at time of definitive mastectomy.

Procedure: Nipple Delay surgery

Interventions

Nipple Delay surgery PROCEDURE

The nipple delay surgery will be performed by the plastic surgeon as an outpatient procedure in the minor procedure room under local anaesthetic 7 - 21 days prior definitive NSM with IBR. The skin flap will be elevated in the plane of the prophylactic mastectomy beneath the NAC. A nipple core biopsy and a 1cm thick biopsy of immediately subareolar ductal tissue will be submitted for permanent section pathology. This approach is consistent with the previous case series of nipple delay for NSM and has been approved by the multi-disciplinary breast cancer team at our institutions. Patients that have a positive nipple core or sub-areolar biopsy will have the NAC removed at time of definitive mastectomy.

Nipple Delay Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 years and above
• Implant-based immediate breast reconstruction
• Prophylactic mastectomy for risk reduction OR
• Therapeutic mastectomy for ductal carcinoma in situ (DCIS) or early stage breast cancer where:
• a. Tumor size \< 3cm b. Tumor to nipple distance \> 2cm c. Clinically negative lymph nodes d. No skin involvement, inflammatory breast cancer or Paget's disease

You may not qualify if:

• Previous ipsilateral breast irradiation
• Regnault ptosis grade II or III
• Breast size of D cup or greater
• Active smoker 7. Are there any age,

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 18, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 2, 2015

Record last verified: 2015-10