Patient Clinical Trials

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ACE Study

Topic of Study: Breast Cancer
Sponsor: Susan G Komen for the Cure
Principal Investigator: Lisa Gallicchio, PhD
Study Coordinator: Carla Calhoun, MBA, MSW, 410-649-3462
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

The Aromatase Inhibitor Cardiovascular Health Evaluation (ACE) Study will examine the cardiovascular (heart) health of breast cancer patients during their first year of aromatase inhibitor (AI) treatment and determine whether AIs affect the cardiovascular health of African-American breast cancer patients differently than Caucasian breast cancer patients. This study is for women diagnosed with postmenopausal, early-stage (stages I and II) breast cancer who are initiating AI (Femara, Arimidex or Aromasin) treatment. Funded by Susan G. Komen for the Cure®.

BELLE-2

Topic of Study: Breast Cancer
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

The purpose of this phase III trial to determine whether the addition of daily BKM120 to fulvestrant (also known as Faslodex®) is effective and safe in treating patients with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer whose disease has progressed on or after aromatase inhibitor treatment. (Novartis CBKM120F2302, ClinicalTrials.gov ID#: NCT01610284)

BROCADE

Topic of Study: Breast Cancer
Sponsor: AbbVie
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

The purpose of this phase II trial is to evaluate the efficacy and tolerability of oral veliparib, a PARP inhibitor, in subjects with BRCA1 or BRCA2 mutation and metastatic breast cancer. Subjects will be randomized to one of three treatment regimens: Veliparib in combination with Temozolomide (TMZ), Veliparib in combination with carboplatin and paclitaxel, or placebo in combination with carboplatin and paclitaxel. (AbbVie M12-895, ClinicalTrials.gov ID#: NCT01506609)

Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab

Topic of Study: Lung Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: Sandy Kotiah, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

This randomized phase III trial is studying carboplatin, paclitaxel, bevacizumab (if appropriate) in order to compare how well they work with or without cetuximab in treating patients with stage IV or recurrent non-small cell lung cancer. This study is for newly diagnosed stage IV disease OR recurrent disease after prior surgery and/or irradiation. (SWOG S0819; ClinicalTrials.gov ID#: NCT00946712)

A Single Arm Prospective Multicenter Study Evaluating the Biodesign® Plastic Surgery Matrix

Topic of Study: Breast Cancer
Sponsor: Cook Biotech Incorporated
Principal Investigator: Brendan J. Collins, M.D., 401-332-9700
Research Coordinator: Irene van Gaalen, PA-C, 410-332-5488
For More Information: 410-951-7950
Coordinated Through: The Breast Reconstruction and Restoration Center at Mercy

This study is designed for patients desiring nipple reconstruction following surgery for breast cancer and breast reconstruction. Eligible patients will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK® Biodesign® Plastic Surgery Matrix. The study is designed to evaluate the benefit of this device in achieving effective and aesthetic nipple reconstruction. Patients will be evaluated at the time of the procedure and at 1 week, 4 weeks, 3 months, 6 months, and 12 months after surgery to examine the projection of their reconstructed nipple(s) and patient satisfaction (Cook Medical Study 09-009; Clinicaltrials.gov ID#: NCT01216319).

Hormone Therapy With or Without Everolimus in Treating Patients with Breast Cancer

Topic of Study: Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

This randomized phase III trial is studying how well giving hormone therapy together with or without everolimus works in treating patients with high-risk, hormone receptor-positive, HER2-negative breast cancer. (SWOG S1207, ClinicalTrials.gov ID#: NCT01674140)

Kaitlin

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

This is a phase III trial comparing trastuzumab + pertuzumab + taxane following versus trastuzumab emtansine + pertuzumab, following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer. (Roche BO28407, ClinicalTrials.gov ID#: NCT01966471

KATHERINE

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

This phase III study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab (also known as Herceptin®) as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. (Roche BO27938 / NSABP B-50-I / GBG 77, ClinicalTrials.gov ID#: NCT01772472)

Lisinopril or Carvedilol Phosphate in Reducing Side Effects in Women with HER2-Positive Breast Cancer Receiving Trastuzumab

Topic of Study: Breast Cancer
Sponsor: SunCoast CCOP Research Base at the University of South Florida
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

The primary object of this phase II trial is to determine if administration of lisinopril (an ACE Inhibitor) or Coreg CR® (β-blocker), compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant, therapy for HER2-positive breast cancer (SCUSF 0806, ClinicalTrials.gov ID#: NCT01009918)


Observational Study to Define the Microbiologic and Immune Characteristics of Peritoneal Tissues in Patients with Appendiceal Cancer with Peritoneal Spread

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, MD, FACS, 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-783-5828
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

The primary aim of the study is to determine the microbiological environment of the peritoneal tissues of patients undergoing cytoreductive surgery with intraoperative hyperthermic chemotherapy for appendix cancer with peritoneal spread.

PROMIS

Topic of Study: Breast Cancer
Sponsor: Agendia
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

This is a prospective, observational study that will assess the impact of MammaPrint on treatment decisions (chemotherapy plus endocrine versus endocrine alone) in patients with an intermediate score by Oncotype DX®.  MammaPrint is an FDA-cleared test that may be used to identify which early-stage breast cancer patients are at risk of distant recurrence following surgery. (Clinicaltrials.gov ID#: NCT01617954)

Radiation Therapy with or without Trastuzumab in Treating Women with Ductal Carcinoma In Situ (DCIS) Who Have Undergone Lumpectomy

Topic of Study: Breast Cancer
Sponsor: National Surgical Adjuvant Breast and Bowel Project
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

The purpose of this study is to compare the effect of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy versus radiation alone. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-postive “invasive” breast cancers. Radiation therapy is the standard treatment for patients with DCIS. (NSABP B-43, Clinicaltrials.gov ID#: NCT00769379)

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients with Invasive RxPONDER Breast Cancer

Topic of Study: Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200 and Sarah Ruff, RN, 410-332-9459
For More Information: 410-951-7950
Coordinated Through: Prevention & Research Center

The objective of this phase III clinical trial is to determine the effect of endocrine therapy with or without chemotherapy in patients with node-positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®.  (SWOG S1007, Clinicaltrials.gov ID#: NCT01272037)