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Research Studies
Mercy’s widely-regarded physicians and clinical team work diligently to provide unparalleled care, beginning with providing the most sophisticated, leading-edge therapies. Physician experts work in tandem with The Prevention & Research Center at Mercy, focusing on translating research into clinical care and bridging breakthrough findings into emerging treatments. Mercy’s specialized research teams are actively involved in innovative clinical trials and research studies which cross multiple medical disciplines and seek to advance the treatment of countless diseases.
Working closely with prestigious national research institutes and health foundations, Mercy’s experts are dedicated to conducting vital research leading to breakthroughs in prevention, diagnosis and treatment.
Current Research Studies>
Breast Cancer Studies
Melanoma Studies
Appendiceal Studies
Lung Studies
Neuroendocrine Studies
Other Studies
Past Research Studies>
These government cooperative group studies are ongoing, but not recruiting participants. Patients continue to be monitored in long-term follow-up. If results have been made public, a brief summary and link to more information is provided below.
Breast Cancer Trials
Current Research Studies
Breast Cancer Trials
ACE study
Sponsor: Susan G. Komen for the Cure®
Principal Investigator: Lisa Gallichio, PhD
Study Coordinator: Carla Calhoun, MBA, MSW, 410-646-3462
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.
APHINITY
Sponsor: Breast International Group (BIG), Genentech, Inc. and F. Hoffmann-La Roche, Ltd.
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
The APHINITY Study will evaluate Pertuzumab in Addition to Chemotherapy and trastuzumab (also called Herceptin®) as Adjuvant Therapy in Patients with HER2-positive primary breast cancer. This study is for patients who are newly diagnosed with primary invasive breast cancer that is HER2-positive. (BIG 4‐11/Roche BO25126/Genentech TOC4939G, ClinicalTrials.gov ID#: NCT01358877)
BELLE-2
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This 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 patinets with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer whose disease has progressed on or after aromatase inhibitor treatment. (Norvartis CBKM120F2302, ClinicalTrials.gov ID#: NCT01610284).
Chemotherapy With or Without Trastuzumab after Surgery in Treating Women with Invasive Breast Cancer
Sponsors: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This phase III trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer. For the B-47 trial, HER2-low is defined as either an IHC score of 1+ or an IHC score of 2+ with negative in situ hybridization. (NSABP B-47, ClinicalTrials.gov ID#: NCT01275677)
Lisinopril or Carvedilol Phosphate in Reducing Side Effects in Women with HER2-Positive Breast Cancer Receiving Trastuzumab
Sponsor: SunCoast CCOP Research Base at the University of South Florida
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
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)
PARP Inhibitor for Women with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Sponsors: Abbott Laboratories
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
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. (Abbott M12-895, ClinicalTrials.gov ID#: NCT01506609)
Radiation Therapy with or without Trastuzumab in Treating Women with Ductal Carcinoma In Situ (DCIS) Who Have Undergone Lumpectomy
Sponsors: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
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)
Technology Enhanced Nurse Navigation Trial (TENN)
Sponsor: Susan G. Komen for the Cure
Principal Investigator: Kathy J. Helzlsouer, MD, MHS, 410-951-7950
Research Nurse: Ashley Price, 410-332-4945
The goal of the TENN℠ Trial is to compare two ways of providing breast cancer patients with information and support through an internet-connected computer. This study is for women diagnosed with breast cancer within the last 3 months and receiving adjuvant therapy and who meet eligibility criteria (income that does not exceed 300% of the Federal Poverty Level, based on family size). Participants will be given internet connectivity. Funded by Susan G. Komen for the Cure.
A Single Arm Prospective Multicenter Study Evaluating the Biodesign® Plastic Surgery Matrix
Sponsor: Cook Biotech Incorporated
Principal Investigator: Brendan J. Collins, M.D., 401-332-9700
Research Physician Assistant: Irene van Gaalen, PA-C, 410-332-5488
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; Clincialtrials.govID#NCT01216319)
Standard Adjuvant Therapy with or without Metformin
Sponsor: National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
The primary object of this phase III trial is to determine whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring in women with recently diagnosed early stage breast cancer. (NCIC CTG MA.32, ClinicalTrials.gov ID#: NCT01101438)
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients with Invasive RxPONDER Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
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)
Melanoma Trials
Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection vs. Sentinel Lymphadenectomy Alone in Melanoma Patients
Sponsor: John Wayne Cancer Institute
Principal Investigator: Armando Sardi, MD, FACS, 410-332-9294
Study Coordinator: Lisa McConnell, RN, 410-332-1200
The purpose of this study is to find out if melanoma can be treated by removing only a few lymph nodes (called "sentinel nodes") (called a "sentinel node dissection") or if all lymph nodes in a lymph basin must be removed (called a "complete lymph node dissection"). (ClinicalTrials.gov ID#: NCT00389571)
Appendiceal Studies
Observational Study to Define the Microbiologic and Immune Characteristics of Peritoneal Tissues and Blood in Patients with Appendiceal Cancer with Peritoneal Spread
Principal Investigator: Armando Sardi, MD, FACS, 410-332-9294
Study Coordinator: Michelle Sittig, RN, 410-783-5828
The primary aim of the study is to determine the microbiological environment of the peritoneal tissues and blood of patients undergoing cytoreductive surgery and intraoperative hyperthermic chemotherapy for appendix cancer with peritoneal spread.
Lung Studies
Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab
Sponsor: Southwest Oncology Group
Principal Investigators: Sandy Kotiah, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
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. (ClinicalTrials.gov ID#: NCT00946712)
Neuroendocrine Studies
Everolimus and Octreotide with or without Bevacizumab in Treating Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigators: Sandy Kotiah, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This randomized phase II trial is studying how well giving everolimus and octreotide (also known as Sandostatin®) together with or without bevacizumab works in treating patients with locally advanced or metastatic pancreatic neuroendocrine tumors that cannot be removed by surgery. (CALGB 80701, ClinicalTrials.gov ID#: NCT01229943)
RADIANT-4
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigators: Sandy Kotiah, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This is a Phase III Study of everolimus plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced (unresectable or metastatic) Neuroendocrine Tumors of GI or Lung origin. Patients never previously treated and those previously treated with Somatostatin Analogs (SSA), Interferon (IFN), one prior line of chemotherapy, and/or Peptide receptor radionuclide therapy (PRRT) are allowed into this study. (Novartis CRAD001T2302, ClinicalTrials.gov ID#: NCT01524783)
Other Studies
Diagnostic Yield of Narrow Band Imaging (NBI) and standard visible white light laparoscopy for the detection of endometriosis
Sponsor: Olympus America Inc.
Principal Investigators: Fermin F. Barrueto Sr., MD, FACOG and Kathy J. Helzlsouer, MD, M.H.S.
Study Coordinator: Benjamin Wolf, BS, 410-951-7958
This multi-center study aims to determine the degree to which NBI improves the detection and diagnosis of endometriosis lesions. Women undergoing diagnostic laparoscopy for suspected endometriosis will be eligible. Participants will receive laparoscopic examination with either standard white light and NBI or standard white light only. Funded by Olympus. (ClinicalTrials.gov ID#: NCT01464775)
Past Research Studies
These government cooperative group studies are ongoing, but not recruiting participants. Patients continue to be monitored in long-term follow-up. If results have been made public, a brief summary and link to more information is provided below.
Breast Cancer Trials
Assessment of Clinical Cancer Tests Assigning Individualized Options for Treatment
Sponsor: Eastern Cooperative Oncology Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
In this trial, the OncotypeDx Breast Cancer Assay will be used to guide treatment decisions in women whose lymph nodes do not contain cancer but whose tumor is either Estrogen Positive and/or Progesterone Positive. (The TAILORx Trial, ClinicalTrials.gov Study ID: NCT00310180)
BETH Study: Treatment of HER2 Positive Breast Cancer with Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab
Sponsor: Cancer International Research Group, Hoffmann-La Roche, and Genentech
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This trial is being conducted to determine if adding the drug Bevacizumab to regimens of chemotherapy in patients with node positive or high risk node negative HER2 positive breast cancer will improve invasive disease free survival. (ClinicalTrials.gov Identifier: NCT00625898)
Bisphosphonate Breast Cancer Study
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This study is being done to find how well adding a bisphosphonate (e.g., Boniva) to hormone or chemotherapy will help to prevent future recurrence of breast cancer in bones and other parts of the body. (SWOG S0307, ClinicalTrials.gov Study ID: NCT00127205)
Chemotherapy for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This study compares the value of adding the drug bevacizumab (also called Avastin®) to a non-anthracycline-based chemotherapy regimen (docetaxel and cyclophosphamide (TCB)) relative to the same chemotherapy without bevacizumab (docetaxel and cyclophosphamide (TC)) and relative to an anthracycline-based chemotherapy regimen (docetaxel, doxorubicin, and cyclophosphamide (TAC)). (NSABP B-46-I/USOR 07132, ClinicalTrials.gov ID#: NCT00887536)
Chemotherapy With or Without Bevacizumab in Treating Women with Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, BSN, OCN, 410-332-1200
This study is for women who have breast cancer and have not yet had surgery. The main purpose of the study is to learn how breast cancer tumors respond to several different chemotherapy combinations with or without the drug bevacizumab. (NSABP B-40, ClinicalTrials.gov Study ID: NCT00408408)
Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, BSN, OCN, 410-332-1200
This randomized phase III trial is studying two combination chemotherapy regimens (Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) versus Four Cycles Of Adriamycin And Cyclophosphamide (AC)) to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes. (NSABP B-36, ClinicalTrials.gov Study ID: NCT00087178)
Docetaxel in Breast Cancer
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This phase III trial compares docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (AC→T) as adjuvant treatment of operable breast cancer HER2 negative patients with positive axillary lymph nodes.
(BCIRG 005, NCT00312208)
Trial Results: For the primary endpoint, Disease-Free Survival, adjuvant TAC is equivalent to AC-T in patients with HER2 negative, node positive breast cancer. For more information on the trial’s results, please see: http://www.bcirg.org/Internet/Studies/In+Breast+Cancer/BCIRG+005.htm
Femara® Versus Placebo
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
This trial will study whether or not continuing hormonal therapy with Femara®, an aromatase inhibitor (AI), for 5 additional years after already taking 5 years of hormonal therapy can further reduce the chance of breast cancer recurrence. (NSABP B-42, ClinicalTrials.gov Study ID: NCT00382070)
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: Neil Friedman, MD, FACS, 410-783-5858
The purpose of this trial is to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women. (NSABP P-2, ClinicalTrials.gov Study ID: NCT00003906)
Trial Results: Prior to the STAR trial, 5 years of tamoxifen was shown to reduce the risk of breast cancer among women at high risk of breast cancer, compared to women taking a placebo pill. The STAR trial was done to compare tamoxifen to raloxifene. The STAR trials results showed that after 5 years of treatment, tamoxifen and raloxifene were equally effective in reducing the risk of invasive breast cancer. Adverse side effects were less with raloxifene than tamoxifen, including less uterine cancer and blood clot risk.
Continued follow-up of the women who took part in the trial showed that, both tamoxifen and raloxifene showed persistent breast cancer risk reduction after stopping treatment, but raloxifene had retained 76% of the effectiveness of tamoxifen in preventing invasive disease. These results help to clarify that both raloxifene and tamoxifen are good preventive choices for postmenopausal women who are at higher risk for breast cancer.
For more information on the trial’s results, please see: http://www.nsabp.pitt.edu/NSABP_Bibliography.asp. Talk to your health care provider to find out more about your risk of breast cancer and whether tamoxifen of raloxifene is right for you. Both of these medications are approved for breast cancer risk reduction among women at increased risk of breast cancer.
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Principal Investigator: Neil Friedman, MD, FACS, 410-783-5858
This trial was designed to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer. (NSABP B-32, ClinicalTrials.gov Study ID: NCT00003830)
Trial Results: No significant differences were observed in Overall Survival, Disease-Free Survival, or regional control between the trial groups. Within the limits of this trial, sentinel node resection without conventional axillary dissection is validated as a safe and effective method for regional node treatment of sentinel node negative breast cancer patients. For more information on the trial's results, please see: http://www.nsabp.pitt.edu/NSABP_Bibliography.asp
Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes after Chemotherapy
Sponsor: American College of Surgeons
Principal Investigator: Gauri Bedi, MD, FACS
Research Nurse: Lisa McConnell, RN, 410-332-1200
This phase II trial is studying the role of surgery to remove the sentinel lymph node and axillary lymph nodes following preoperative chemotherapy in treating in women with node positive breast cancer (T1-4, N1-2, M0) at initial diagnosis. (ACOSOG-Z1071, ClinicalTrials.gov Study ID: NCT00881361)
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Sponsor: International Breast Cancer Study Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Nurse: Lisa McConnell, RN, 410-332-1200
The purpose of this phase III trial is to study triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer. (IBCSG 25-02, ClinicalTrials.gov Study ID: NCT00066703)
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