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Breast Surgery Trials

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 – lllA, Must enroll after neoadjuvant chemotherapy

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, CCRP at 847.570.1681, srabbitt@northshore.org

Open to Enrollment: Yes

 

Impact of an In-Visit Decision Aid on Uninformed Decision Making for Contralateral Prophylactic Mastectomy

Aims: To determine whether using an online decision intervention directly with patients will increase patient knowledge resulting in less patients making uninformed decisions to undergo contralateral prophylactic mastectomy.

Diagnosis: Breast cancer. Participants must enroll prior to breast surgery.

Principal Investigator: Katharine Yao, MD

IRB Approval Number: EH17-045

Sponsor:  NorthShore University HealthSystem

Contact:  Interested patients may contact Sandra Simovic at 847.570.4227, ssimovic@northshore.org

Open to Enrollment:  Yes

 

MarginProbe System Post-Approval Study Protocol CP-07-001

Aims: To determine if the MarginProbe accurately determines if the edges of the removed tissue is clear from cancer in real time and to see if it can reduce the number of incomplete resections that require a repeat surgery.

Diagnosis: Breast cancer. Participants must enroll prior to breast surgery.

Principal Investigator: Katherine Kopkash, MD

IRB Approval Number: EH18-074

Sponsor:  Dune Medical Device, Inc.

Contact:  Interested patients may contact Mary Turk at 847.570.1184, mturk@northshore.org

Open to Enrollment:  Yes

 

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS:  a Phase III Prospective Randomized Trial (AFT-25)

Aims:  To compare the risks and benefits of the usual treatment approach for ductal carcinoma in situ (DCIS) with a close monitoring approach (Active Surveillance).  Usual treatment is a combination of surgery, radiation and/or endocrine therapy.  Active Surveillance is close monitoring without surgery or radiation and with or without endocrine therapy.

Diagnosis: Low Risk Ductal Carcinoma in Situ (DCIS)

Principal Investigator:  Katharine Yao, MD

IRB Approval Number:  EH17-072

Sponsor:  Alliance Foundation Trials, LLC

Contact:  Interested patients may contact Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org

Open to Enrollment:  Yes