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New treatment option for Anatomic Stage 0 Breast Cancer AJCC v8
Official title Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
ClinicalTrials.gov ID: NCT06153836
What this study is testing
- What it's testing
- This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female patients age \>= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Planned nipple sparing mastectomy (NSM)
- Ideal NSM candidates would meet the following criteria:
- Cup size A-C
You likely can't join if
- Planned autologous reconstruction (immediate or delayed)
- Pregnancy
See the full eligibility criteria
- Female patients age \>= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Planned nipple sparing mastectomy (NSM)
- Ideal NSM candidates would meet the following criteria:
- Cup size A-C
- BMI \<34
- Ptosis grade \< 2
- Clinical stage 0 - T2N0
- Final planned implant volume \< 400cc
- Inframammary or lateral mammary incision
- Tumor \> 0.5cm from the nipple areolar complex (NAC)
- No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM
- No prior breast radiation on side of planned NSM
- Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement)
- No planned post mastectomy radiation (PMRT)
- No nicotine use within 4 weeks of surgical date
- Planned autologous reconstruction (immediate or delayed)
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.