RECRUITING

Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling

Talk to us

Conditions

HER2-negative Breast CancerNSABPCelcuityHER2-negativeinvasivebreast cancerOpen-labelNeoadjuvantEarly stageDoxorubicinCyclophosphamidePaclitaxelTrastuzumabPertuzumabCELx HSFHER2 Signaling Function testanti-HER2 Antibodies

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2018-05-14
Study Completion:2023-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03412643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Nodal status - negative: Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative;
  2. * Nodal status - positive: FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive. Imaging is suspicious or abnormal but FNA or core biopsy was not performed.
  3. * Immunohistochemistry (IHC) 0-1+; or
  4. * IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to chromosome enumeration probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells; or
  5. * ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells.
  6. * absolute neutrophil count (ANC) must be greater than or equal 1200/mm3;
  7. * platelet count must be greater than or equal 100,000/mm3; and
  8. * hemoglobin must be greater than or equal 10 g/dL.
  9. * total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
  10. * alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and
  11. * aspartate aminotransferase (AST) must be less than or equal to 1.5 x ULN for the lab.
  12. * Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than or equal to 2.5 x ULN, the AST must be less than or equal to the ULN. If the AST is greater than the ULN but less than or equal to 1.5 x ULN, the alkaline phosphatase must be less than or equal to ULN. Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be less than or equal to 1.5 x ULN; if both were performed, the AST must be less than or equal to 1.5 x ULN.
  1. * Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis.
  2. * History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy.

Contacts and Locations

Study Contact

Director, Department of Site and Study Management
CONTACT
1-800-270-3165
industrytrials@nsabp.org

Principal Investigator

Norman Wolmark, MD
PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc

Study Locations (Sites)

Arrowhead Regional Medical Center
Colton, California, 92324
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
University of Florida Cancer Center at Orlando Health
Orlando, Florida, 32806
United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
United States
Edward Hospital Cancer Center
Naperville, Illinois, 60540-7499
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Louisville JG Brown Cancer Center
Louisville, Kentucky, 40202
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Herbert Herman Cancer Center, Sparrow Hospital
Lansing, Michigan, 48912
United States
Ascension St. Mary's
Saginaw, Michigan, 48601
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
University of Rochester - Wilmot Cancer Institute
Rochester, New York, 14642
United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
United States
Aultman Hospital
Canton, Ohio, 44710
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Arthur G. James Cancer Hospital & Richard Solove Research Institute
Columbus, Ohio, 43210
United States
Columbus Oncology & Hematology Associates Inc
Columbus, Ohio, 43214
United States
The Mark H. Zangmeister Center
Columbus, Ohio, 43219
United States
Doctors Hospital
Columbus, Ohio, 43228
United States
Adena Regional Medical Center
Columbus, Ohio, 45601
United States
Dayton Clinical Oncology Program
Dayton, Ohio, 45420
United States
Dayton Physicians LLC
Dayton, Ohio, 45420
United States
Delaware Health Center
Delaware, Ohio, 43015
United States
Marietta Memorial Hospital Cancer Center
Marietta, Ohio, 45750
United States
Marion General Hospital
Marion, Ohio, 43303
United States
Knox Community Hospital
Mount Vernon, Ohio, 43050
United States
Licking Memorial Hospital
Newark, Ohio, 43055
United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
United States
Genesis Health Care
Zanesville, Ohio, 43701
United States
Wellspan Health - York Cancer Center
York, Pennsylvania, 17403
United States
Harris Health Systems-Smith Clinic
Houston, Texas, 77030
United States
Lester and Sue Smith Breast Center
Houston, Texas, 77030
United States
Centra Lynchburg Hematology Oncology
Lynchburg, Virginia, 24501
United States
Bon Secours Richmond Community Hospital Medical Oncology Assoc.
Mechanicsville, Virginia, 23116
United States
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
United States
Bon Secours Richmond Community Hospital at St. Mary's
Richmond, Virginia, 23226
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
Ascension St. Elizabeth Hospital
Appleton, Wisconsin, 54915
United States

Collaborators and Investigators

Sponsor: NSABP Foundation Inc

  • Norman Wolmark, MD, PRINCIPAL_INVESTIGATOR, NSABP Foundation Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-14
Study Completion Date2023-10-30

Study Record Updates

Study Start Date2018-05-14
Study Completion Date2023-10-30

Terms related to this study

Keywords Provided by Researchers

  • NSABP
  • Celcuity
  • HER2-negative
  • invasive
  • breast cancer
  • Open-label
  • Neoadjuvant
  • Early stage
  • Doxorubicin
  • Cyclophosphamide
  • Paclitaxel
  • Trastuzumab
  • Pertuzumab
  • CELx HSF
  • HER2 Signaling Function test
  • anti-HER2 Antibodies

Additional Relevant MeSH Terms

  • HER2-negative Breast Cancer