Breast Cancer Clinical Trial
Official title:
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
| Verified date | March 2018 |
| Source | University of Miami |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | April 2021 |
| Est. primary completion date | April 2020 |
| 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. - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determination of the Recommended Phase II Dose (RP2D) 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 | Surgery Success Rate | 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. | Up to 12 months | |
| Secondary | Levels of Cosmetic Outcome in Study Participants - Number | Levels of 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). Data will be summarized in terms of number of patients in these 4 possible categories at those assessment times separately for assessment by physician and by patient. | 3, 6 and 12 months | |
| Secondary | Levels of Cosmetic Outcome in Study Participants - Percentage | Levels of 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). Data will be summarized in terms of percentage of patients in these 4 possible categories at those assessment times separately for assessment by physician and by patient. | 3, 6 and 12 months | |
| Secondary | Disease-Free Survival Rate in Study Participants | Disease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death. | Up to 5 years | |
| Secondary | Overall Survival Rate in Study Participants | Overall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact.. | Up to 5 years | |
| Secondary | Recurrence Rate in Study Participants | Rate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof. | Up to 5 years |
