Clinical trial · Interventional
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer
NCT01208974CI-TRIAL-00121816completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ductal Carcinoma | Breast Ductal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Surgery | Procedure | — | UNRESOLVED |
| Breast Reconstruction | Procedure | — | UNRESOLVED |
| Nipple-Sparing Mastectomy | Procedure | — | UNRESOLVED |
| Prophylactic Nipple-Areolar Complex RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1 MTD NAC RT
- description
- 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.
- interventionNames
- Procedure: Nipple-Sparing Mastectomy
- Procedure: Breast Reconstruction
- Procedure: Axillary Surgery
- Radiation: Prophylactic Nipple-Areolar Complex RT
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed in-situ or invasive breast carcinoma. * Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm. * Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins. * No extensive intraductal component or patient with distant metastases. * Patients must be \> 18 years of age. * No concomitant or history of nipple discharge or skin involvement. * No prior history of malignancy (less than 5 years prior to study entry), except non-melanomatous skin cancer. * No prior history of radiation to the chest. * No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No previous non-hormonal therapy including radiation or chemotherapy for current breast cancer. * No patients with Paget's disease of the nipple. * No patients with co-existing medical conditions with life expectancy \< 2 years. * No pregnant or lactating women. * Eastern Cooperative Oncology Group (ECOG) 0 - 2. * Signed study-specific informed consent form prior to the study entry. Exclusion Criteria: * Retroareolar breast cancer lesions within one cm, depth from the skin surface. * Concomitant or history of nipple discharge or skin involvement. * Patient with distant metastases. * Patient with extensive intraductal carcinoma. * Any previously irradiated ipsilateral breast cancer. * Patients with Paget's disease of the nipple. * Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or dermatomyositis. * Other malignancy, except nonmelanomatous skin cancer, less than 5 years prior to participation in this study. * Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females. * Positive surgical margins following nipple sparing mastectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.