NSABP B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Aims: The purpose of this study is to compare the effectiveness of three different combinations of chemotherapy drugs: 1) docetaxel and cyclophosphamide; 2) doxorubicin, cyclophosphamide and docetaxel; and 3) doxorubicin, cyclophosphamide and paclitaxel. All of these drugs are used in standard combinations of chemotherapy for breast cancer. The researchers also want to learn about the side effects of the combinations of drugs used in this study to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
Diagnosis: Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH12-341
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Contact: Interested patients should contact research nurse Michele Britto at 847.570.2109
Open to Enrollment: Yes
UC 09-056-B: Investigation of Genetic Determinants of Capecitabine Toxicity
Aims: The purpose of this study is to find out if your genes have a role in certain side effects you may experience while taking capecitabine. Genes are the material that is passed from parents to children that determine the make-up of the body. This study focuses on the side effects of diarrhea, hand-foot syndrome (a condition that causes the skin on your hands and feet to become red and peel away), and a drop in your white blood cell count (which can increase the risk of infection).
Diagnosis: Metastatic Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH09-355
Sponsor: The University of Chicago
Contact: Interested patients should contact research nurse Michele Britto at 847.570.2109 or research coordinator Nancy Haefling at 847.503.1188
Open to Enrollment: Yes
NCIC MA.32: A Phase III Randomized Trial Of Metformin Versus Placebo On Recurrence And Survival In Early Stage Breast Cancer
Aims: This study is looking at whether Metformin, a drug 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 your other therapy to keep your cancer from recurring. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.
Diagnosis: Early Stage Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH11-053
Sponsor: National Cancer Institute of Canada
Contact: Interested patients should contact research nurse Michele Britto at 847.570.2109
Open to Enrollment: Yes
LPT112515: A Randomized, Phase III, Open-Label Study of Lapatinib plus Trastuzumab versus Trastuzumab as Continued HER2 Suppression Therapy after Completion of first- or Second-line Trastuzumab plus Chemotherapy in Subjects with HER2-positive Metastatic Breast Cancer
Aims: The purpose of this study is to test the safety and effectiveness of the drug lapatinib when used in combination with the drug trastuzumab in patients with HER2-positive breast cancer that has spread to other parts of the body. HER2 (also known as Human Epidermal growth factor Receptor 2) is a protein that increases the aggressiveness of tumors. Participants in this study will receive either lapatinib plus trastuzumab or trastuzumab alone. The combination of lapatinib and trastuzumab is considered experimental because it has not been approved by the FDA at this time.
Diagnosis: HER2-positive Metastatic Breast Cancer
Principal Investigator: Leon Dragon, MD
IRB Approval Number: EH10-193
Sponsor: GlaxoSmithKline
Contact: Interested patients should contact research nurse Michele Britto at 847.570.2109
Open to Enrollment: Yes
EH10-244: Peritumoral Fat as a Promoter of Invasive Breast Carcinoma
Aims: The purpose of this study is to evaluate fat tissues around breast cancers and in non-affected breast tissue. Through the study, we hope to gain understanding of how fat tissues may promote breast cancer progression. Patients who agree to participate in this study will have a blood sample obtained during pre-operative testing and undergo a bilateral breast MRI on the 3.0 Tesla (higher strength magnet) at Evanston Hospital prior to surgery. After standard pathologic review of the breast tissue is completed, fat biopsies are taken from each of the 4 quadrants of the breast(s) and submitted to the Research Institute for analysis and storage. Patients will not be provided the results of any analyses done for research purposes.
Diagnosis: Breast Cancer
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH10-244
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact study coordinator Brigid Martz at 847.570.1681 or bmartz@northshore.org
Open to Enrollment: Yes
EH88-077: The Establishment and Maintenance of the NorthShore University HealthSystem Comprehensive Data Registry for Breast Surgeries and Breast Tissue Bank
Aims: The purpose of this study is to collect information about patients undergoing a breast procedure (including excisional biopsy, surgery for benign disease, surgery for treatment and cosmetic procedures). This study is being done to understand the natural history of the disease, to learn what kinds of treatment are most beneficial, and to track the patients' progress with lifetime follow up. The majority of follow up data is collected from EPIC (NorthShore's electronic medical record system), but private physicians and patients may be contacted via phone if additional information is needed. Data is entered into a secured computerized database with access limited to the principal investigator, co-investigators and research personnel.
Diagnosis: Breast Cancer or Breast Surgery
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH88-077
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact study coordinator Mary Turk at 847.570.1184 or mturk@northshore.org
Open to Enrollment: Yes
EH12-014: Improved MRI Images of High Risk Lesions
Aims: The purpose of this study is to determine whether the use or breast MRI in patients with high-risk breast lesions can help identify patients who have risk-lesions that could be managed with survellance rather than surgical excision. Patients with high-risk breast lesions are recommended to have surgical excision as standard of care. As part of this research study, study participants would undergo a research-MRI prior to surgical excision. This is done at Evanston Hospital and paid for by the study (MRI is not billed to insurance and results are not added to the medical record). Patients are provided a $50 stipend for undergoing a research-MRI with contrast agent.
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH12-014
Sponsor: Illinois Department of Public Health and University of Chicago Collaborative Pilot Award
Contact: Interested patients should contact study coordinator Brigid Martz at 847.570.1681 or bmartz@northshore.org
Open to Enrollment: Yes
EH12-385: Young and Strong: An Educational and Supportive Care Intervention Study for Young Women with Breast Cancer
Aims: To improve the health of young women recently diagnosed with breast cancer by use of an educational and supportive intervention. Through this study we hope to learn more about the experience of young women diganosed with breast cancer.
Diagnosis: Breast cancer diagnosed 18-45
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH12-385
Sponsor: Dana Farber
Contact: Interested patients should contact study coordinator Mary Turk at 847.570.1184 or mturk@northshore.org
Open to Enrollment: Yes