biomarker study of immune-mediated mechanism of action of neoadjuvant trastuzumab in her2+ breast cancer patients

Conditions: Cancer, Breast

Summary: 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)

women with histologically confirmed her2-positive 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.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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., intrathoracic, 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 goirc-01-2016 immunher protocol version 1.0, 11 april 2016 page 6 of 140 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. * concurrent malignancy or malignancy within 3 years prior to study enrollment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or insitu carcinoma of the uterine cervix. * pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study). * women of childbearing potential that refusal to adopt adequate contraceptive measures. * unwilling or unable to comply with the protocol. -