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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT04109261
Eligibility Criteria:
Inclusion Criteria:
1. Patients with RH+ y HER2- metastatic breast cancer having progressed to at least 4 previous standard treatment lines in the metastatic setting, and are not eligible to receive palbociclib in a clinical trial
2. Absolute neutrophil count ≥1,500/mm3 (1.5 x 109/L)
3. Platelet count ≥100,000/mm3 (100 x 109/L)
4. Haemoglobin ≥9 g/dL
5. Creatinine ≤1.5 x ULN or creatinine clearance ≥ 60 mL/min
6. Total bilirubin ≤1.5 x ULN (≤3.0 x ULN in case of Gilbert's disease)
7. AST and/or ALT ≤3 x ULN (≤5.0 x ULN in case of hepatic metastases)
8. Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN in case of hepatic or bone metastases)
Exclusion Criteria:
1. Major surgery, chemotherapy, radiotherapy, treatment with an investigational drug or any other active anticancer therapy within two weeks of treatment initiation
2. Previous radiotherapy in ≥25% of bone marrow
3. QTc \>480 msec, personal or family past history of short or long QT syndrome, Brugada's syndrome, or past history of QT interval prolongation, or tachycardia with Torsade de Pointes (TdP)
4. History of any of the following conditions within 6 months of treatment initiation: myocardial infarction, unstable angina, grade ≥2 arrhythmia (CTCAE version 4.0), atrial fibrillation, coronary or peripheral artery by-pass, symptomatic congestive heart failure, stroke, or pulmonary thromboembolism
5. Known hypersensitivity to palbociclib
6. Current or recent suicidal ideation or behaviour
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04109261
Study Brief:
Protocol Section:
NCT04109261