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

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.

Conditions

HER2-negative Breast Cancer

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Study Overview

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Study Details

Study overview

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.

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

Condition
HER2-negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Colton

Arrowhead Regional Medical Center, Colton, California, United States, 92324

Miami Beach

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Orlando

University of Florida Cancer Center at Orlando Health, Orlando, Florida, United States, 32806

Decatur

Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States, 62526

Naperville

Edward Hospital Cancer Center, Naperville, Illinois, United States, 60540-7499

Fort Wayne

Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States, 46804

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Louisville

University of Louisville JG Brown Cancer Center, Louisville, Kentucky, United States, 40202

New Orleans

University Medical Center New Orleans, New Orleans, Louisiana, United States, 70112

Baltimore

Greater Baltimore Medical Center, Baltimore, Maryland, United States, 21204

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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;
  • * 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.
  • * Immunohistochemistry (IHC) 0-1+; or
  • * 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
  • * 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.
  • * absolute neutrophil count (ANC) must be greater than or equal 1200/mm3;
  • * platelet count must be greater than or equal 100,000/mm3; and
  • * hemoglobin must be greater than or equal 10 g/dL.
  • * 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
  • * alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and
  • * aspartate aminotransferase (AST) must be less than or equal to 1.5 x ULN for the lab.
  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NSABP Foundation Inc,

Norman Wolmark, MD, PRINCIPAL_INVESTIGATOR, NSABP Foundation Inc

Study Record Dates

2023-10-30