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:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT01387295
Eligibility Criteria:
Inclusion Criteria:• Informed consent
* Age \> 18 years
* Performance status 0-1; expected survival ≥ 3 months
* Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
* Liver metastases not suitable for local treatment
* Extrahepatic disease should be determined by PET-CT-scan.
* No progression on treatment with capecitabine.
* Prior treatment with taxane (adjuvant or for metastatic disease)
* Metastases \< 70 % of the liver
* Neutrophile granulocytes \> 1.5 x 109/l og thrombocytes \> 100 x 109/l
* Bilirubin \< 2.0 x UNL (upper normal limit).
* Creatinine-clearance \> 30 ml/min.
* INR \< 1.6.
* If the patient is HER2-positive:Baseline LVEF ≥ 50 %
Exclusion Criteria:
* History of chemotherapy within the 4-week period prior to the start of trial medication
* Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
* Previous treatment with oxaliplatin
* Cytotoxic or experimental treatment within a 14 days period before start of trial medication
* The patient is not allowed to participate in other clinical trials.
* Any clinical symptoms suggesting peripheral neuropathy \< or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
* Other severe medical conditions e.g. severe cardial disease or AMI \< 1 year
* Presence of diseases which prevent oral therapy.
* Patients with uncontrolled infection
* Pregnant or lactating women
* Women capable of childbearing not using a sufficient non-hormonal method of birth control
* Patients not able to understand the treatment or to collaborate.
* Prior serious or unsuspected reaction after treatment with fluoropyrimidine
* Known prior hypersensitivity reactions to the agents
If the patient is HER2-positive:
* Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01387295
Study Brief:
Protocol Section:
NCT01387295