TNBC: Avatar: Feasibility/Pilot Study of Genomics-Guided Therapeutic Drug Selection for Triple Negative Breast Cancer (TNBC) Using a Patient-Derived Mouse Xenograft
Aims: The purpose of this study is to see if tumor genetics, PDX mouse model and cell lines can be helpful in predictions which treatment would be most effective for an individual breast cancer pateint. In addition, if your cancer returns, doctors may be able to use their information learned from treating the PDX mouse to guide the choice of treatment for your cancer.
Diagnosis: Triple negative breast cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH15-066
Sponsor: The Jackson Laboratory
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes 

Novartis: CRQAD001JUS226: A Phase II, Single Arm Study of the Use of Steroid-Based Moutwash to Prevent Stomatitis in Postmenopausal Women with Advanced or Metastatic Hormone Receptor Positive Breast Cancer Being Treateted with Everolimus Plus Exemestane
Aims: The purpse of this study is to evaluate the effectiveness of an investigational sterioid-based mouth wash, and to see if it can help prevent or reduce the severity and duration of oral stomatitis, a common side effect of Everolimus.
Diagnosis: Advanced or Metastatic Hormone Receptor Positive Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH15-063
Sponsor: Novartis Oncology
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

LATTE: Long Term Anastrozole versus Tamoxifen Treatment Effects
Aims: The LATTE study is an extension study to the now closed ATAC trial that took place 10 years ago. LATTE aims to collect long term follow-up information since the conclusion of the ATAC study and for at least another 5 years.
Diagnosis: Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH13-352
Sponsor: American Cancer Society, Inc/ Queen Mary University of London
Contact: Interested patients should contact research coordinator Nancy Haefling at 847.503.1188
Open to Enrollment: Yes 

UC13-1-000: Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Presistent Epithelial Ovarian Cancer
Aims: The purpse of this study is to find the safest dose of mifepristone when given with standard chemotherapy using carboplatin and gemcitabine. The study will look at the side effects, how your body processes the drugs, and the effects of the drug combination on your body and your cancer.
Diagnosis: Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH14-248
Sponsor: University of Chicago
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

AbbVie M12-914: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer 
Aims: The main purpose of the study is to determine if veliparib in combination with carboplatin and paclitaxel improves the efficacy of chemotherapy alone in participants with a BRCA1 or BRCA2 mutation and HER2-negative metastatic or locally advanced breast cancer. Carboplatin and paclitaxel are chemotherapy drugs are widely used as a treatment for advanced or metastatic (spread to/from other areas) breast cancer.
Diagnosis: Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH14-199
Sponsor: AbbVie
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

A011106: ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study
Aims: The purpse of this study is to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer.
Diagnosis: Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH14-308
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

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 and left over breast tissue from patients with breast surgery to help learn about breast cancer prevention, early detection of breast cancer and what kinds of breast cancer treatment are most beneficial. In addition, information about the surgical outcomes of cosmetic and reconstructive breast surgery will be collected.
Diagnosis: Breast Cancer & Benign Breast Conditions
Principal Investigator:
Katharine Yao, M.D
IRB Approval Number: 
EH88-077
Sponsor:
  NorthShore University HealthSystem
Contact: Interested patients may contact Mary Turk, CTR, CCRP at 847.570.1184, mturk@northshore.org
Open to Enrollment: Yes

Developing and Maintenance of a Comprehensive Breast Reconstruction Registry at NorthShore University HealthSystem
Aims: To track long-term satisfaction following breast reconstruction.
Diagnosis: Breast cancer. Participants must enroll prior to breast reconstruction surgery.
Principal Investigator:
Mark Sisco, MD
IRB Approval Number:
EH11-124
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Agnes Brugger, RN, CCRP 847.570.1632, kbrugger@northshore.org
Open to Enrollment: Yes

The NorthShore Study of Surgical Decision-Making and Quality of Life Outcomes after Breast Cancer Surgery
Aims: To discover the decision-making pathway in newly diagnosed breast cancer patients.
Diagnosis: Breast cancer. Participants must enroll prior to breast surgery.
Principal Investigator:
Mark Sisco, MD
IRB Approval Number:
EH14-218
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Agnes Brugger, RN, CCRP 847.570.1632, kbrugger@northshore.org
Open to Enrollment: Yes

Piloting an In-Visit Decision Aid for Sugical Decision Making in Breast Cancer Patients
Aims: The purpose of this study is to develop a decision aid that can be used by surgeons to help patients decide which surgical procedure to choose for their newly diagnosed breast cancer. Additionally, we would like to learn more about a patient’s knowledge about breast cancer and the treatment for it and what affects a woman’s decision when making her choice for surgery.
Diagnosis: Breast Cancer
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH14-020
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org
Open Enrollment:
 
Yes

Phase II Study of Neoadjuvant Letrozole for Post-Menopausal Women with Estrogen Receptor Positive Ductal Carcinoma in Situ (DCIS)
Aims: The purpse of this study is to test whether neoadjuvant (meaning given before surgery) treatment with aromatase inhibitor (anti-hormonal medication) called Letrozole has an effect, eithe rgood or bad, on you and on the DCIS. Mammograms are the standard method of detecting and measuring DCIS. In this study, we would also like to learn more about whether Magnetic Responance Imaging (MRI) may be better for evaluating and measuring DCIS when compared to mammograms.
Diagnosis: Breast Cancer
Principal Investigator: Katherine Yao, MD
IRB Approval Number: EH13-408
Sponsor: Cancer and Leukemia Group B
Contact: Interested patients may contact Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org
Open to Enrollment: Yes

A011104: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer
Aims: The purpse of this study is to test whether patients undergoing breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated uding mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.
Diagnosis: Breast Cancer, Clinical Stage I-II
Principal Investigator: Katherine Yao, MD
IRB Approval Number: EH14-346
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Marna Burright, RN at 847.570.1697mburright@northshore.org or Sarah Rabbitt, RN at 847.570.1681 srabbitt@northshore.org
Open to Enrollment: Yes

Improved MRI Images of High Risk Breast Lesions
Aims: The purpse of this study is to determined whether the use of breast MRI in patients with high-risk breast lesions can help us identify patients who have high-risk lesions that could have been managed with surveillance rather than surgical excision.
Diagnosis: Breast Cancer
Principal Investigator: Katherine Yao, MD
IRB Approval Number: EH12-014
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Mary Turk, CTR, CCRP at 847.570.1184, mbturk@northshore.org or Sarah Rabbitt, RN at 847.570.1681, srabbitt@northshore.org
Open to Enrollment: Yes

NSABP B-55/BIG 6-13: A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olparib Versus Placebo as Adjuvant Treatement in patients with Germline BRAC1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definiteive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Aims: The purpse of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer. In this study, you will get either olaparib or placebo.
Diagnosis: BreastGermline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer
Principal Investigator: Douglas Merkel, MD
IRB Approval Number: EH14-400
Sponsor: NSABP
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

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