Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01208974
Other study ID # 20090299
Secondary ID SCCC-2009004
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 16, 2010
Est. completion date May 31, 2025

Study information

Verified date April 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 21
Est. completion date May 31, 2025
Est. primary completion date February 13, 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. - 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.

Study Design


Intervention

Procedure:
Nipple-Sparing Mastectomy
Subcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1.
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. Performed during Week 1.
Axillary Surgery
Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
Radiation:
Prophylactic Nipple-Areolar Complex RT
Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.

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 Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation. The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0. Up to 13 weeks
Secondary Cosmetic Outcome Cosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported. 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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2