Clinical trial NCT04109261: Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe
Official title: Retrospective Observational Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic breast cancer included in a compassionate use programme

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- breast cancer previously treated with at least 4 treatment lines for advanced disease. During this period, approximately 400 patients have received treatment within this programme. Since this population of patients more pre-treated was not included in the studies for regulatory submission, the collection of efficacy and toxicity data in the clinical practice setting is of clinical interest.


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

Primary outcomes:
measure: Time to progression
timeFrame: through study completion, up to 9 months
Secondary outcomes:
measure: Number of adverse events
timeFrame: through study completion, up to 9 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fernando Moreno
Study officials:
References: