Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03811418
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated written informed consent prior to beginning of protocol-specific procedures.
* Histologically or cytologically confirmed adenocarcinoma of the breast. Locally advanced and inoperable or metastatic disease.
* HER2-positive disease, defined as IHC status HER2+++ or CISH/FISH status positive.
* Female patients aged ≥ 18 years.
* In case of adjuvant treatment, disease-free interval of at least 12 months after completion of adjuvant treatment (excluding hormonal therapy).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
* For women with childbearing potential, defined as physiologically capable of becoming pregnant:
* Negative pregnancy test.
* Agreement to use an effective form of contraception during study treatment and for 7 months after the last dose of study treatment.
* Life expectancy of at least 12 weeks.
* Adequate organ and bone marrow function
* Fluent in spoken and written German and willing to answer the questionnaires
Exclusion Criteria:
* Previous systemic treatment in palliative intention (chemotherapy, hormonal therapy and / or biological therapy)
* Persistent peripheral sensory or motor neuropathy grade 2 or higher (NCI CTCAE v5.0)
* Evidence of central nervous system metastases. CT or MRI of the brain is only mandatory in case of clinical suspicion of brain metastases
* Current uncontrolled hypertension (systolic \> 150 mmHg and / or diastolic \> 100 mmHg) or clinically significant cardiovascular disease
* History of LVEF \< 50% during or after prior (neo)adjuvant therapy with trastuzumab
* Current severe, uncontrolled systemic disease (e.g. cardiovascular, pulmonary, or metabolic disease, wound healing disorder, ulcers, or bone fractures, or severe fungal, bacterial or viral infection)
* Major surgery within 28 days prior to start of study medication, or anticipation of the need for major surgery during the course of study treatment
* Current known infection with HIV, HBV, or HCV (testing not required)
* Dyspnea at rest due to complications of advanced malignancy, or other diseases requiring continuous oxygen therapy.
* Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.
* Participation in investigational studies within 30 days or five half-lives of the respective IMP, whichever is longer, prior randomization.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03811418
Study Brief:
Protocol Section:
NCT03811418