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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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Ductal Carcinoma

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Trial Information

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


- 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.


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 margins.

- 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.

- 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
dermatomyosis.

- Other malignancy, except non-melanomatous 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.

- Patients with BRCA 1-2 mutations.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the recommended phase II dose of post-operative prophylactic NAC irradiation.

Outcome Description:

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.

Outcome Time Frame:

2 to 3 Years

Safety Issue:

Yes

Principal Investigator

Cristiane Takita, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20090299

NCT ID:

NCT01208974

Start Date:

October 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Ductal Carcinoma
  • Breast Cancer
  • Nipple Area Complex
  • Mastectomy
  • Radiation Therapy
  • Nipple-Sparing
  • Breast Reconstruction
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location

University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136