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 predictioning which treatment would be most effective for an individual breast cancer patient. 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 

EA1131: Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy versus Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Aims: The purpose of this study is to compare the usual approach, which is no further treatment to receiving additional chemotherapy after surgery. 
Diagnosis: Triple negative breast cancer
Principal Investigator: James Ward, MD
IRB Approval Number: EH15-332
Sponsor: ECOG-ACRIN
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes 

NSABP B-51: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Aims:
The purpose is to study patients who have cancer cells in the lymph nodes when they are diagnosed with breast cancer and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. The study will find out if after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping the cancer from returning and if after mastectomy, radiation to the area where the breast used to be and to the lymph nodes, is better than no radiation to keep the cancer from recurrence.
Diagnosis: Breast cancer
Principal Investigator: James Ward, MD
IRB Approval Number: EH15-334
Sponsor: NRG Oncology
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes 

CBYL719C2301:SOLAR-1: A Phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
Aims: To find out if the experimental drug alpelisib is safe and has beneficial effects when given with the commercially available drug fulvestrant to men or postmenopausal women with hormone receptor-positive breast cancer
Diagnosis: Breast cancer
Principal Investigator: James Ward, MD
IRB Approval Number: EH15-312
Sponsor: Novartis Pharmaceuticals
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes 

UC13-1-000: Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer
Aims: The purpose 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 that 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 purpose 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 Surgical 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 purpose of this study is to test whether neoadjuvant (meaning given before surgery) treatment with an aromatase inhibitor (anti-hormonal medication) called Letrozole has an effect, either good 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 Resonance 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 during 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 r Sarah Rabbitt, RN at 847.570.1681 srabbitt@northshore.org
Open to Enrollment: Yes

Improved MRI Images of High Risk Breast Lesions
Aims: The purpose of this study is to determine 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

A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3, N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
Aims:
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection. 
Diagnosis: Breast Cancer, Clinical Stage II-IIIA
Principal Investigator: Catherine Pesce, MD
IRB Approval Number: EH15-297
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact  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 Olaparib Versus Placebo as Adjuvant Treatment in patients with Germline BRAC1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Aims: The purpose 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