Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
• Collaborators: Arithmos srl; Clirest s.r.l.; Mipharm SpA; Temas srl; University Hospital of Parma: Department of Biomedical, Biotechnological and Translational Sciences, Pathological Anatomy and Histology Unit; University Hospital of Parma:Laboratory of Viral Immunopathology, Unit of Infectious Diseases and Hepatology; University Hospital of Parma:Statistica medica ed epidemiologia clinica-UO Ricerca e Innovazione
• Treatments: Docetaxel; Pertuzumab; Trastuzumab

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. -