Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced/Inflammatory HER2-positive Breast Cancer (ImmunHER) - ImmunHER protocol

GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 sites60 target enrollmentDecember 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)

•Previously untreated, infiltrating primary breast cancer with locally advanced, inflammatory, or early stage tumor (either greater than 2 cm in diameter or node positive) with no evidence of metastatic disease.
•HER2 positivity (either immunohistochemistry 3\+ or fluorescent in situ hybridization amplification).
•Age 18 or older.
•Eastern Cooperative Oncology Group performance status of 0 to 1\.
•Availability of tumor tissue for biologic and molecular examination before starting primary treatment.
•Left ventricular ejection fraction within the institutional range of normal.
•Normal organ and marrow function.
•Adequate contraception methods for women of childbearing potential.
•Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years.
•Written informed consent.

•Either stage I or IV breast cancer.
•Prior trastuzumab or pertuzumab.
•Any prior chemotherapy.
•Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
•Undergone major surgery (e.g., intra\-thoracic, intra\-abdominal or intra\-pelvic) \<\= 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
•Breast radiotherapy prior to starting study.
•Known hypersensitivity to the investigational drugs or any of their excipients.
•Evidence of any disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or puts the patient at high risk for treatment\-related complications.
•Moderate/severe hepatic impairment (Child\-Pugh B/C).
•Uncontrolled inter\-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.