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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01208974
Other study ID # 20090299
Secondary ID SCCC-2009004
Status Recruiting
Phase N/A
First received September 22, 2010
Last updated September 29, 2017
Start date March 16, 2010
Est. completion date April 2019

Study information

Verified date September 2017
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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 this phase I study.


Description:

- 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date April 2019
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

- 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.

Study Design


Intervention

Procedure:
Nipple-Sparing Mastectomy
Nipple-Sparing Mastectomy with Immediate Breast Reconstruction followed by Prophylactic Nipple-Areolar Complex Radiation
Immediate Breast Reconstruction
Immediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire.
Axillary surgery
At surgeon's discretion.
Radiation:
Prophylactic Nipple-Areolar Complex RT
Nipple-sparing Mastectomy with Immediate Breast Reconstruction followed by Prophylactic Nipple-Areolar Complex Radiation

Locations

Country Name City State
United States University of Miami Sylvester Comprehensive Cancer Center Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the recommended phase II dose of post-operative prophylactic NAC irradiation. The recommended phase II dose will be the highest irradiation dose level at which <= 1 out of 6 study patients experiences dose-limiting toxicity (DLT). This dose will be the phase dose II of post-operative prophylactic NAC irradiation after NAC-sparing mastectomy with reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer. 3-5 Years
Secondary To provide extensive descriptive data regarding NAC-sparing surgery with reconstruction, including both surgeon experience and patient evaluation of cosmetic results. Surgery success rate, defined as the proportion of patients who had successful NAC sparing surgery with reconstruction divided by the total number of study patients, will be determined.
Cosmetic results will be assessed by both the physician(s) and the patients at 3, 6 and 12 months, using a 4-category ordinal scale (excellent, good, fair, and poor).
Up to 5 Years
Secondary Survival Up to 5 years
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