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Nipple-Areola Complex Irradiation for Breast Cancer

N/A
Waitlist Available
Led By Cristiane Takita, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No concomitant or history of nipple discharge or skin involvement
Patients must be > 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test if adding radiation to the nipple and areola area after a nipple-sparing mastectomy can help preserve them.

Who is the study for?
This trial is for adults over 18 with breast cancer (Tis, T1, T2) that's less than 4 cm and can be removed by nipple-sparing mastectomy. Participants should have no prior chest radiation or malignancy within the last five years (except certain skin cancers), an ECOG score of 0-2, and a life expectancy over two years. Pregnant or lactating women, those with previous treatments for current breast cancer except hormones, and individuals with certain diseases are excluded.Check my eligibility
What is being tested?
The study tests if adding radiation to the nipple-areola complex after a nipple-sparing mastectomy and immediate reconstruction can safely preserve these areas in patients with specific types of breast cancer. It involves surgical procedures followed by targeted radiotherapy.See study design
What are the potential side effects?
Potential side effects may include skin changes like redness or peeling at the irradiated site, fatigue from radiation therapy, discomfort or complications from surgery such as infection or poor wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no history of nipple discharge or skin issues related to my cancer.
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I am older than 18 years.
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My breast cancer can be fully removed with surgery that spares the nipple.
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I have never had radiation therapy to my chest.
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My breast cancer is in an early stage and the tumor is smaller than 4 cm.
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I haven't had cancer, except for non-dangerous skin cancer, in the last 5 years.
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I am able to get out of my bed or chair and move around.
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I do not have lupus, scleroderma, or dermatomyositis.
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My life expectancy is more than 2 years despite my other health conditions.
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My cancer has not spread far and does not have a large intraductal component.
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I haven't had chemo or radiation for my current breast cancer.
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I do not have Paget's disease of the nipple.
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My breast cancer has been confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
Secondary outcome measures
Cosmetic Outcome
Disease-Free Survival Rate in Study Participants
Overall Survival Rate in Study Participants
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 1 MTD NAC RTExperimental Treatment4 Interventions
Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows: Dose Level I - 10 fractions of 2.0 Gy for a total of 20 Gy Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT). Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,239 Total Patients Enrolled
16 Trials studying Breast Cancer
1,530 Patients Enrolled for Breast Cancer
Cristiane Takita, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Breast Reconstruction Clinical Trial Eligibility Overview. Trial Name: NCT01208974 — N/A
Breast Cancer Research Study Groups: Phase 1 MTD NAC RT
Breast Cancer Clinical Trial 2023: Breast Reconstruction Highlights & Side Effects. Trial Name: NCT01208974 — N/A
Breast Reconstruction 2023 Treatment Timeline for Medical Study. Trial Name: NCT01208974 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being recruited for this trial currently?

"This clinical trial, which first appeared on March 16th 2010 and was last updated in December 2021 is no longer actively recruiting patients. However, 2636 other studies are still searching for participants at this moment."

Answered by AI
~1 spots leftby Mar 2025