Status:
COMPLETED
Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe
Lead Sponsor:
Fernando Moreno Antón
Conditions:
Breast Cancer
Eligibility:
All Genders
18-100 years
Brief Summary
In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the on-going compassionate use programme of palbociclib has enabled drug access to patients with RH+/HER2- brea...
Eligibility Criteria
Inclusion
- 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
- Absolute neutrophil count ≥1,500/mm3 (1.5 x 109/L)
- Platelet count ≥100,000/mm3 (100 x 109/L)
- Haemoglobin ≥9 g/dL
- Creatinine ≤1.5 x ULN or creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤1.5 x ULN (≤3.0 x ULN in case of Gilbert's disease)
- AST and/or ALT ≤3 x ULN (≤5.0 x ULN in case of hepatic metastases)
- Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN in case of hepatic or bone metastases)
Exclusion
- Major surgery, chemotherapy, radiotherapy, treatment with an investigational drug or any other active anticancer therapy within two weeks of treatment initiation
- Previous radiotherapy in ≥25% of bone marrow
- 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)
- 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
- Known hypersensitivity to palbociclib
- Current or recent suicidal ideation or behaviour
Key Trial Info
Start Date :
September 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT04109261
Start Date
September 18 2018
End Date
September 1 2019
Last Update
September 30 2019
Active Locations (1)
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1
Fernando Moreno
Madrid, Spain, 28040