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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01913067
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age\>18, ECOG 0-1
* Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
* In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
* In patients with breast cancer, known estrogen and progesterone receptor status.
* Evidence of measurable disease in the brain (at least 1cm)
* Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.
* No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE) score ≥ 25/30.
* No more than 4 prior lines of systemic chemotherapy in the metastatic setting
* Adequate hematopoietic function defined as:
* Hemoglobin ≥ 9.0g/dL
* Absolute neutrophilic count ≥ 1.5 x 109L
* Platelet count ≥ 100 x 109L
* Adequate hepatic function defined as:
* AST ≤ 2.5 x upper limit of normal (ULN)
* ALT ≤ 2.5 x ULN
* Total bilirubin ≤ 1.0 x ULN
* Adequate renal function defined as serum creatinine ≤ 1.5 x ULN. If creatinine ranges from 1.0 - 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance \>60 mL/min are eligible
* Adequate contraceptive method in patients with child-bearing potential.
Exclusion Criteria:
* History of prior whole brain irradiation
* Progressive neurological symptoms requiring immediate brain irradiation
* Pregnancy or lactation
* History of hypersensitivity reaction to taxanes
* History of hypersensitivity to polysorbate 80 containing agents
* Current or planned treatment with strong inhibitors or inducers of cytochrome P450.
* Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or immunotherapy
* Leptomeningeal carcinomatosis
* Contra-indication to contrast-enhanced MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01913067
Study Brief:
Protocol Section:
NCT01913067