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PREDIX HER2 - preoperative treatment of HER2 positive breast cancer
EU CTIS ID: 2023-508411-23-00
What this study is testing
Evaluate the impact of response-guided treatment on objective response and long-term outcome.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.