Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | March 16, 2010 |
| End Date: | April 2021 |
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
Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and
immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer
will allow better cosmesis and patient's satisfaction:
- The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex)
external beam radiotherapy for selected patient with early stage invasive or in-situ
breast cancers will be technically feasible and with acceptable complication rates.
- The cosmetic results after NAC-sparing mastectomy followed by postoperative external
beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.
- The local control rate in the NAC will be more than expected for a NAC sparing
mastectomy without postoperative radiotherapy.
- The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC
external beam radiotherapy will be better than after Skin Sparing Mastectomy.
immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer
will allow better cosmesis and patient's satisfaction:
- The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex)
external beam radiotherapy for selected patient with early stage invasive or in-situ
breast cancers will be technically feasible and with acceptable complication rates.
- The cosmetic results after NAC-sparing mastectomy followed by postoperative external
beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.
- The local control rate in the NAC will be more than expected for a NAC sparing
mastectomy without postoperative radiotherapy.
- The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC
external beam radiotherapy will be better than after Skin Sparing Mastectomy.
Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic
NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in
patients with ductal carcinoma in-situ or invasive breast cancer.
Primary objective: To determine the recommended phase I dose of post-operative prophylactic
NAC irradiation.
Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery
with reconstruction, including both surgeon experience and patient evaluation of cosmetic
results. Survival and recurrence will be assessed.
Study size: Between 12 and 18 patients will be enrolled in the dose-escalation/deescalation
part of this phase I study. An additional expansion cohort of 12 patients will be enrolled at
the "potential" recommended phase II dose (RP2D) over an expected accrual period of 2 years.
NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in
patients with ductal carcinoma in-situ or invasive breast cancer.
Primary objective: To determine the recommended phase I dose of post-operative prophylactic
NAC irradiation.
Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery
with reconstruction, including both surgeon experience and patient evaluation of cosmetic
results. Survival and recurrence will be assessed.
Study size: Between 12 and 18 patients will be enrolled in the dose-escalation/deescalation
part of this phase I study. An additional expansion cohort of 12 patients will be enrolled at
the "potential" recommended phase II dose (RP2D) over an expected accrual period of 2 years.
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.
We found this trial at
1
site
1475 NW 12th Ave
Miami, Florida 33136
Miami, Florida 33136
(305) 243-1000
Principal Investigator: Eli Avisar, MD
Phone: 866-574-5124
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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