Spots Global Cancer Trial Database for Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling
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Trial Identification
Brief Title: Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling
Official Title: An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)
Study ID: NCT03412643
Conditions
Study Description
Brief Summary: This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing.
Detailed Description: Patients will be required to have a prescreening research core needle biopsy to procure a fresh tumor specimen that will be sent to Celcuity for CELx HSF testing, in order to assess the status of their HER2 signaling activity (abnormally or normally active). Patients who have abnormal HER2 signaling activity will receive weekly paclitaxel plus the anti-HER2 therapy regimen of trastuzumab and pertuzumab following completion of initial doxorubicin/cyclophosphamide.The primary endpoint of the study is to evaluate whether patients with HER2-negative breast cancers based on standard American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) testing criteria, but with abnormal HER2-driven signaling pathways determined by the Celcuity HSF assay and receive HER2-targeted therapy with neoadjuvant chemotherapy, will have a higher rate of pathological complete response in the breast and lymph nodes (pCR breast and lymph nodes) than has been found historically in patients with HER2-negative breast cancer who have received neoadjuvant chemotherapy alone. Secondary endpoints include pathologic complete response (breast), clinical complete response (cCR), residual cancer burden (RCB) 0-1 index, and relationship between quantitative CELx score and pCR rate. It is expected that approximately 270 patients will need to be prescreened in order to enroll 54 patients (26 ER-positive/HER2-negative and 28 ER-negative/HER2-negative) who have abnormal HER2 signaling activity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arrowhead Regional Medical Center, Colton, California, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Florida Cancer Center at Orlando Health, Orlando, Florida, United States
Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States
Edward Hospital Cancer Center, Naperville, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
University of Iowa, Iowa City, Iowa, United States
University of Louisville JG Brown Cancer Center, Louisville, Kentucky, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Herbert Herman Cancer Center, Sparrow Hospital, Lansing, Michigan, United States
Ascension St. Mary's, Saginaw, Michigan, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
University of Rochester - Wilmot Cancer Institute, Rochester, New York, United States
Strecker Cancer Center-Belpre, Belpre, Ohio, United States
Aultman Hospital, Canton, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital & Richard Solove Research Institute, Columbus, Ohio, United States
Columbus Oncology & Hematology Associates Inc, Columbus, Ohio, United States
The Mark H. Zangmeister Center, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Adena Regional Medical Center, Columbus, Ohio, United States
Dayton Clinical Oncology Program, Dayton, Ohio, United States
Dayton Physicians LLC, Dayton, Ohio, United States
Delaware Health Center, Delaware, Ohio, United States
Marietta Memorial Hospital Cancer Center, Marietta, Ohio, United States
Marion General Hospital, Marion, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Genesis Health Care, Zanesville, Ohio, United States
Wellspan Health - York Cancer Center, York, Pennsylvania, United States
Harris Health Systems-Smith Clinic, Houston, Texas, United States
Lester and Sue Smith Breast Center, Houston, Texas, United States
Centra Lynchburg Hematology Oncology, Lynchburg, Virginia, United States
Bon Secours Richmond Community Hospital Medical Oncology Assoc., Mechanicsville, Virginia, United States
Bon Secours St. Francis Medical Center, Midlothian, Virginia, United States
Bon Secours Richmond Community Hospital at St. Mary's, Richmond, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
Ascension St. Elizabeth Hospital, Appleton, Wisconsin, United States
Contact Details
Name: Norman Wolmark, MD
Affiliation: NSABP Foundation Inc
Role: PRINCIPAL_INVESTIGATOR
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