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Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT01208974
Study type Interventional
Source University of Miami
Status Active, not recruiting
Phase N/A
Start date March 16, 2010
Completion date April 2021

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