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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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 nipple-sparing mastectomy and immediate breast reconstruction.

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 data supports the effectiveness of the treatment Prophylactic Nipple-Areolar Complex RT for breast cancer?

The research on regional nodal irradiation (RNI) for breast cancer suggests that targeted radiation can help reduce the chance of cancer coming back in nearby areas and improve disease-free survival, which might imply potential benefits for similar treatments like Prophylactic Nipple-Areolar Complex RT. ^{1 2 3 4 5}

Is nipple-areola complex irradiation safe for humans?

Nipple-sparing mastectomy with intraoperative radiotherapy has been performed on many patients, showing some complications like infections (3%) and partial or total necrosis (tissue death) of the nipple in some cases. However, most patients and surgeons reported good results, and there were no deaths related to the treatment. ^{6 7 8 9 10}

How does nipple-areola complex irradiation differ from other breast cancer treatments?

Nipple-areola complex irradiation is unique because it focuses on preserving the nipple and areola during breast cancer treatment, which can improve cosmetic outcomes and quality of life. This approach combines surgery with targeted radiation to the nipple area, unlike traditional mastectomy that often removes the entire breast, including the nipple. ^{7 8 11 12 13}

Research Team

Cristiane Takita

Principal Investigator

University of Miami

Eligibility Criteria

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.

Signed study-specific informed consent form prior to the study entry

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Benefit of postoperative regional nodal irradiation in patients receiving preoperative systemic therapy with docetaxel/carboplatin/trastuzumab/pertuzumab for HER2-positive breast cancer. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Does the Presence of Cytokeratin Positive Individual Tumor Cells (N0(I+)) in Sentinel Lymph Nodes Affect Clinical Outcomes in Breast Cancer Patients Treated with Accelerated Partial Breast Irradiation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term results of combined-modality therapy for locally advanced breast cancer with ipsilateral supraclavicular metastases: The University of Texas M.D. Anderson Cancer Center experience. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

The curative value of irradiation in the treatment of nondisseminated breast cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Prophylactic supraclavicular fossa radiotherapy in early breast cancer: is it worthwhile? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Spare the Nipple: A Systematic Review of Tumor Nipple-Distance and Oncologic Outcomes in Nipple-Sparing Mastectomy. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

When mastectomy becomes inevitable: the nipple-sparing approach. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Subareolar breast cancer: long-term results with conservative surgery and radiation therapy. [2004]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Conservative mastectomy versus nipple-sparing mastectomy: preliminary considerations of oncological safety on 30 patients not receiving intra-operative radiotherapy. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Oncoplastic partial breast reconstruction improves patient satisfaction and aesthetic outcome for central breast tumours. [2020]

11. Italy pubmed.ncbi.nlm.nih.gov

Conservative treatment of the central breast cancer with nipple-areolar resection: an alternative oncoplastic technique. [2008]

12. United States pubmed.ncbi.nlm.nih.gov

Nipple-areolar preservation during breast-conserving therapy for subareolar breast carcinomas. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Breast conservation surgery using nipple-areolar resection for central breast cancers. [2006]