Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn
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
To compare invasive disease-free survival for the combination of at least 5 years endocrine therapy and 2- year palbociclib treatment vs 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer. Vallabhaneni, Geetha
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun
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
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam
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
Primary Objective:
The primary objective of this study is to assess the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in patients with HR-positive, HER2-negative metastatic breast cancer. This objective will be evaluated in terms of the rate of permanent treatment discontinuation of palbociclib due to neutropenia for each cohort and compare them to
Tan, Antoinette Roslyn
To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. Vallabhaneni, Geetha
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
The primary safety objective for this study is to evaluate the safety and tolerability of the following combination treatments administered q3w to patients with HER2-positive MBC or operable LABC or inflammatory EBC: Atezolizumab in combination with trastuzumab and pertuzumab and Atezolizumab in combination with trastuzumab emtansine Fisher, Julie Gottlieb
To evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. To estimate the clinical activity of combination treatment with niraparib and pembrolizumab in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Phase 2: Approximately 12 months ] [ Designated as Tan, Antoinette Roslyn