Carolinas HealthCare System

Research and Clinical Trials

Breast - Female 

Brief Description Principal Investigator
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy
White, Richard L 
This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer White, Richard L 
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim 
Celera Corporation: Comparison of Breast Cancer Somatic Gene Expression Measurements Calhoun, Ben 
To estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with inoperable locally advanced or metastatic triple negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all patients and in patients with PTEN-low tumors. Tan, Antoinette 
Genentech ML28523: Retrospective Study of the Impact of CEP17 Copy Number Variation Limentani, Steven A 
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex. White, Richard L 
Primary: To assess breast health knowledge among Latino women who have attended a "Living Room Visit" breast education program by comparing pre and post-interventional surveys administered to women immediately before and after education and three months after intervention.
Secondary: To evaluate patterns of survey responses and explore quantitatively the overall feasibility of the community assessment program in terms of completion rate of the 3 month follow-up survey.
Carrizosa, Daniel 
This trial is studying how well hormone therapy or chemotherapy before surgery based on gene expression analysis works in treating patients with breast cancer. Limentani, Steven A 
To determine whether the addition of trastuzumab to chemotherapy (TC or AC?_WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed. Limentani, Steven A 
NSABP B-50-I: A randomized, multicenter, open-label phase III study to evaluate the eff Limentani, Steven A 
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Sharp, Hadley 
To compare invasive disease-free survival (DFS) in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer randomized to either chemotherapy plus 1 year of trastuzumab plus pertuzumab or chemotherapy plus 1 year of trastuzumab emtansine plus pertuzumab. Fisher, Julie 
To compare the pathological complete response (pCR) rate between treatment arms using central evaulation. Limentani, Steven A 
Primary Objective
To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX┬«. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative breast cancer with RS ≤ 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit dep
Schwartz, Garry 
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