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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

Must not have

Positive surgical margins following nipple sparing mastectomy

Retroareolar breast cancer lesions within one cm, depth from the skin surface

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had cancer cells found at the edge of my tissue after a mastectomy preserving the nipple.

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My breast cancer is close to the surface, near the nipple area.

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I have a widespread type of breast cancer that starts in the milk ducts.

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My cancer has spread to distant parts of my body.

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I have had or currently have nipple discharge or skin changes.

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I have had radiation on the same side breast cancer before.

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I have Paget's disease of the nipple.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.

Secondary study objectives

Cosmetic Outcome

Disease-Free Survival Rate in Study Participants

Overall Survival Rate in Study Participants

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 19Eligibility criteria met