CTIS2023-508411-23-00Active, not recruitingPhase 1
PREDIX HER2 - Neoadjuvant response-guided treatment of HER2 positivebreast cancer. Part of a platform of translational phase II trials based onmolecular subtypes
Karolinska University Hospital0 sites200 target enrollmentStarted: September 25, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent, Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker, Tumor and blood samples available. HER2 type confirmed by genomic profiling using Next-Generation Sequencing., Age 18 years or older. Elderly patients in condition adequate for planned therapy, Primary breast cancer >20mm in diameter and/or verified lymph node metastases, Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders, LVEF >55%, ECOG performance status 0-1, Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available.
Exclusion Criteria
- •Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum, Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix, Patients in child-bearing age without adequate contraception, Pregnancy or lactation, Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
Investigators
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