Nipple-Areola Complex Irradiation for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Retroareolar lesions, Metastases, Paget's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether radiation can preserve the nipple and areola after a mastectomy and breast reconstruction. It evaluates the safety and effectiveness of adding radiation to these areas. Participants receive controlled radiation doses, known as Prophylactic Nipple-Areolar Complex RT, and may also opt for chemotherapy. This trial suits individuals with breast cancer that is small (less than 4 cm), surgically removable, and without skin involvement or discharge. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve post-mastectomy outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this radiation treatment is safe for preserving the nipple-areola complex?

Research has shown that radiation treatment on the nipple and areola can be safe and effective after a nipple-sparing mastectomy. Earlier studies found this treatment to be safe and feasible. Most patients tolerated it well, with very few serious side effects.

The studies reported a low cancer recurrence rate of 1.4% in the treated area, suggesting the treatment helps prevent cancer from returning. These results are based on follow-ups lasting from about 9 to 58 months after surgery.

Overall, current evidence supports that this radiation treatment is generally well-tolerated and safe for patients, with a low chance of cancer recurrence in the treated areas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prophylactic Nipple-Areolar Complex (NAC) radiation treatment because it aims to preserve the nipple-areola complex during mastectomy for breast cancer, which is not typically the focus of standard treatments. Most current options involve mastectomy with reconstruction, often without specific radiation targeting the NAC. This trial is unique as it explores different doses of radiation specifically to the NAC, potentially minimizing side effects while maintaining effectiveness. By sparing the NAC and using a precise radiation approach, this treatment could enhance cosmetic outcomes and patient satisfaction after surgery.

What evidence suggests that this radiation treatment is effective for preserving the nipple-areola complex in breast cancer patients?

Research has shown that adding radiation to the nipple and areola after a nipple-sparing mastectomy can be effective. In this trial, participants will undergo a dose-escalation/de-escalation of prophylactic Nipple-Areolar Complex radiation treatment (RT). One study followed patients for 10 years after this treatment, and none experienced a recurrence of breast cancer in the treated area. Another study with 300 cases found that over 80% of patients and surgeons rated the cosmetic results as good. This indicates that the treatment not only helps maintain a natural appearance but also reduces the risk of cancer returning in the treated area. ^{1 6 7 8 9}

Who Is on the Research Team?

Cristiane Takita

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Reconstruction

Participants undergo a nipple-areolar complex-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated

1 week

1 visit (in-person)

Radiation Treatment

Participants receive prophylactic NAC radiation treatment with dose escalation/de-escalation over 5 days

5 days

10 visits (in-person, twice daily)

Chemotherapy (optional)

Standard of care chemotherapy may be initiated at the treating physician's discretion

Varies

Follow-up

Participants are monitored for safety, cosmetic outcomes, and disease recurrence

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic Nipple-Areolar Complex RT

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1 MTD NAC RT Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study of 300 nipple-sparing mastectomies with intraoperative radiotherapy, 82.3% of patients and 84.8% of surgeons rated the aesthetic results as good, indicating high satisfaction with the procedure.

While there were some complications, including 10 cases of total NAC necrosis and a 3% infection rate, the overall oncological outcomes were positive, with only two local recurrences and no deaths reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When mastectomy becomes inevitable: the nipple-sparing approach. Petit, JY., Veronesi, U., Luini, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01208974?cond=Areola&viewType=Table&rank=9

NCT01208974 | Nipple-Areola Complex (NAC) Irradiation ... The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10266511/

No Cancer Occurrences in 10-year Follow-up after ... Assessing a cohort of patients with 10 years of follow-up from prophylactic NSM, there have been zero incidences of locoregional breast cancer ...

3. withpower.com withpower.com/trial/phase-1-carcinoma-ductal-2-2010-0f08d

Nipple-Areola Complex Irradiation for Breast Cancer In a study of 300 nipple-sparing mastectomies with intraoperative radiotherapy, 82.3% of patients and 84.8% of surgeons rated the aesthetic results as good, ...

4. abs.amegroups.org abs.amegroups.org/article/view/6412/html

Narrative review of the application of radiotherapy in nipple ... The removal of the nipple-areola complex (NAC) can result in physical and psychological distress for patients (3). Although the appearance of the breast can be ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11723670/

Innovations in Nipple-areolar Complex Reconstruction The NAC may provide patients with a sense of normalcy by serving as a focal point for the breast. Moreover, women scored significantly higher on ...

6. redjournal.org redjournal.org/article/S0360-3016(18)31562-1/fulltext

Final Results of Phase I Study of Prophylactic Nipple ... Conclusion. Prophylactic NAC RT was safe and feasible after NSM with immediate reconstruction in this selected cohort of patients. Most ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6006016/

Evidence based outcomes of the American Society ... A 1.4% (n=12) recurrence rate (mean follow-up of 31 months, median follow-up of 27 months), with a range of 9.7–58.3 months since surgery was noted. Of the 12 ...

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2749070

Breast Cancer Recurrence in Nipple-Areola Complex After ... This cohort study assesses the incidence of and risk factors and outcomes associated with breast cancer recurrence of the nipple-areola ...

9. clinicaltrial.be clinicaltrial.be/fr/details/13110?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Nipple-Areola Complex (NAC) Irradiation After Nipple-Spar... The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas ...