PREDIX HER2 - preoperative treatment of HER2 positive breast cancer

Phase 1

Conditions: Primary breast cancer
MedDRA version: 20.0Level: PTClassification code: 10006201Term: Breast cancer stage III Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10006188Term: Breast cancer female NOS Class: 10029104
MedDRA version: 20.0Level: PTClassification code: 10006200Term: Breast cancer stage II Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10006191Term: Breast cancer male NOS Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-508411-23-00

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the impact of response-guided treatment on objective response and long-term outcome.;Secondary Objective: Identify tumor characteristics and treatment-related changes of tumor biology predictive of long-term prognosis.;Primary end point(s): Pathological objective response to primary medical treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Clinical/radiological objective response during neoadjuvant treatment;Secondary end point(s):Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer;Secondary end point(s):Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS);Secondary end point(s):Safety;Secondary end point(s):Quality of life;Secondary end point(s):Frequency of breast-conserving surgery