Clinical trial · Interventional

Nipple Delay Prior to Nipple Sparing Mastectomy: A Pilot RCT

NCT02526719CI-TRIAL-00019671withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Study design changed, no longer a randomized trial design

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Nipple Delay surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
NO_INTERVENTION
label
Standard Nipple-Sparing Mastectomy
description
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.
type
EXPERIMENTAL
label
Nipple Delay Intervention
description
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patient age 18 years and above
2. Implant-based immediate breast reconstruction
3. Prophylactic mastectomy for risk reduction OR
4. 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

Exclusion Criteria:

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

References

Publications (0)

Data not yet available

No reference posted for this study.