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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreTrial 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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer cells found at the edge of my tissue after a mastectomy preserving the nipple.I have no history of nipple discharge or skin issues related to my cancer.I am older than 18 years.My breast cancer can be fully removed with surgery that spares the nipple.I have never had radiation therapy to my chest.I have not had cancer, other than non-dangerous skin cancer, in the last 5 years.My breast cancer is close to the surface, near the nipple area.I have a widespread type of breast cancer that starts in the milk ducts.My breast cancer is in an early stage and the tumor is smaller than 4 cm.I haven't had cancer, except for non-dangerous skin cancer, in the last 5 years.I am able to get out of my bed or chair and move around.My cancer has spread to distant parts of my body.I do not have lupus, scleroderma, or dermatomyositis.My life expectancy is more than 2 years despite my other health conditions.I have had or currently have nipple discharge or skin changes.I have had radiation on the same side breast cancer before.My cancer has not spread far and does not have a large intraductal component.I haven't had chemo or radiation for my current breast cancer.I do not have Paget's disease of the nipple.You have certain conditions like lupus, scleroderma, or dermatomyositis.My breast cancer has been confirmed by a biopsy.I have Paget's disease of the nipple.You are pregnant or breastfeeding because the treatment might harm the baby or affect breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 MTD NAC RT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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