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 Laverne 
This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer White, Richard Laverne 
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo 
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 Roslyn 
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) and assess the safety of GDC-0810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-)breast cancer. Tan, Antoinette Roslyn 
The primary efficacy objective is to estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with early stage TNBC, as measured by local pathology laboratory evaluation of pCR rate within the breast and exilla (ypT0/Tis ypN0) in all patients and in patients with PTEN-low tumors. Fisher, Julie Gottlieb 
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 Laverne 
Primary: to compare radioactive seed localization (RSL) and wire-guided localization (WL) based on negative margins in malignant disease where negative margins is defined as no tumor on ink in invasive disease, and greater than or equal to 2mm from the inked margin in non-invasive disease (DCIS).
Secondary: to compare RSL and WL base on the following: total procedure cost, subject satisfaction over time, time from subject consult to operating room, radiologist satisfaction, time in radiology, s
Hadzikadic-Gusic, Lejla 
To evaluate the objective response rate (ORR) to pembrolizumab as 2L+ monotherapy in subjects with PD-L1(+)high centrally confirmed mTNBC, based on RECIST 1.1 as assessed by central radiology review. Tan, Antoinette Roslyn 
NSABP B-50-I: A randomized, multicenter, open-label phase III study to evaluate the eff Limentani, Steven Amedeo 
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 Jean 
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
Williams, Richard Franklin 
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