Impact of an In-Visit Decision Aid on Uniformed Decision Making for Contralateral Prophylactic Mastectomy
Aims: To determine whether using an online decision intervention directly with patients will increase patient knowledge resulting in fewer patients making uninformed decisions to undergo contralateral prophylactic mastectomy.
Diagnosis: Breast Cancer- Participants must enroll prior to breast surgery
Principal Investigator: Katherine 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
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
A Prospective, Multicenter Investigation of the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures
Aims: This study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in prophylactic Nipple Sparing Mastectomy procedures. Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex.
Diagnosis: Increased Risk for Breast Cancer
Principal Investigator: Katherine Kopkash, MD
IRB Approval Number: EH19-074
Sponsor: Intuitive Surgical
Contact: Interested patients may contact Anne Jankowski at 847.570.1512 AJankowski@northshore.org
Open to Enrollment: Yes
A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
Aims: This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM. This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Diagnosis: DCIS and/or invasive breast carcinoma clinical stage Tis, T1, T2 with N0.
Principal Investigator: Katherine Kopkash, MD
IRB Approval Number: EH23-039
Sponsor: Intuitive Surgical
Contact: Interested patients may contact Anne Jankowski at 847.570.1512 AJankowski@northshore.org
Open to Enrollment: Yes
BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation
Aims: This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.
Diagnosis: Confirmed BRCA1 mutation
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH22-349
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Anne Jankowski at 847.570.1512 AJankowski@northshore.org
Open to Enrollment: Yes