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BO40747

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer (Clinicaltrials.gov ID#: NCT03726879).

BIG 16-05/AFT-27/WO39391

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a research study comparing Atezolizumab (Anti-PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triplenegative breast cancer. (Clinicaltrials.gov ID#: NCT03498716)

BWEL

Topic of Study: Breast Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). This study will help to show whether weight loss programs should be a part of breast cancer treatment. (Clinicaltrials.gov ID#: NCT02750826)

BYLIEVE

Topic of Study: Breast Cancer
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase II randomized trial evaluate the efficacy and Safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2- negative advanced breast cancer (aBC), who have progressed on or after CDK 4/6 inhibitor treatment. (Clinicaltrials.gov ID#: NCT03056755)

CO40016

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a double-blind, placebo-controlled, randomized phase III study of ipatasertib in combination with paclitaxel as a treatment for patients with PIK3CA/AKT1/PTEN-altered, locally advanced or metastatic, triple-negative breast cancer or hormone receptor–positive, HER2-negative breast cancer  (Clinicaltrials.gov ID#: NCT03337724).

DESTINY

Topic of Study: Breast Cancer
Sponsor: Daiichi Sankyo Inc
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This trial compares DS-8201a, an anti-HER2-antibody drug conjugate, versus standard of care for HER2-positive, unresectable and/or metastatic breast cancer subjects pretreated with prior standard of care HER2 therapies, including T-DM1. (ClinicalTrials.gov ID#: NCT03523585)


EA1131

Topic of Study: Breast Cancer
Sponsor: ECOG ACRIN Cancer Research Group
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase III trial to determine how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with triple-negative breast cancer who have residual disease following neoadjuvant chemotherapy and surgery. (Clinicaltrials.gov ID#: NCT02445391)

EMERALD

Topic of Study: Breast Cancer
Sponsor: Radius Pharmaceuticals Inc
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This trial compares the efficacy and safety of elacestrant to the standard of care fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on at least one endocrine therapy. (ClinicalTrials.gov ID#: NCT03778931)


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).

FLEX

Topic of Study: Breast Cancer
Sponsor: Agendia
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome information to look at the Agendia Breast Cancer suite and new gene associations. The Agendia Breast Cancer Suite includes MammaPrint® and BluePrint™, which are tests that help your doctor analyze and profile your breast cancer tumor. DiscoverPrint is for research purposes only. (Clinicaltrials.gov ID#: NCT03053193)

Insulin

Topic of Study: Breast Cancer
Sponsor: Mt Sinai NY
Principal Investigator: Neil B. Friedman, M.D., 410-332-9330
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459 and Andrea Gerbasio CRA, 410-951-7908
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This study is researching the link between insulin resistance and breast cancer prognosis in African American and Caucasian women.

NATALEE

Topic of Study: Breast Cancer
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (Clinicaltrials.gov ID#: NCT03701334).

POLARIS

Topic of Study: Breast Cancer
Sponsor: Pfizer
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a non-interventional trial for patients receiving palbociclib for their hormone positive advanced breast cancer.  (Clinicaltrials.gov ID#: NCT03280303)

 

SWOG S1418

Topic of Study: Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase III randomized trial evaluate the efficacy and safety of pembrolizumab for women with triple-negative breast cancer who have residual invasive cancer or positive lymph nodes after neoadjuvant chemotherapy. (Clinicaltrials.gov ID#: NCT02954874)

TARGIT-US

Topic of Study: Breast Cancer
Sponsor: University of California San Francisco
Principal Investigator: Neil B. Friedman, MD, 410-332-9330
Study Coordinator: Andrea Gerbasio, 410-951-7908
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This is an observational study for women who are receiving Intraoperative Radiation Therapy (IORT) following breast-conserving surgery. (ClinicalTrials.gov ID#: NCT01570998)