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CompletedNCT04109261PALBOCOMPUpdated Sep 30, 2019

Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe

An observational study in Breast Cancer, sponsored by Fernando Moreno Antón. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Fernando Moreno Antón · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
237
Ages
18 Years to 100 Years
Sex
All
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's enrollment of 237 is above the median of 185 across 2,712 observational studies indexed under Breast Neoplasms.

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Lead sponsor

This is the only study on the registry with Fernando Moreno Antón as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with metastatic breast cancer included in a compassionate use programme

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
237 participants (actual)
Patient registry
No

Groups and cohorts

  • Palbociclib treatment

    Drug: Palbociclib

Interventions

  • DrugPalbociclib

    Palbociclib administration in breast cancer patients included in a compassionate use programme. Patients were treated according to the standard of care

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What researchers measure

Primary outcomes

  1. Time to progression

    Number of days between the beginning of the treatment with palbociclib and the progression

    Time frame: through study completion, up to 9 months

Secondary outcomes

  1. Number of adverse events

    Number of adverse events between the beginning of the treatment with palbociclib and the progression

    Time frame: through study completion, up to 9 months

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Study locations

1 site
  • Fernando Moreno
    Madrid, 28040, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04109261
Lead sponsor
Fernando Moreno Antón
Responsible party
Fernando Moreno Antón (Principal Investigator, Hospital San Carlos, Madrid) — Sponsor-investigator
First posted
Sep 30, 2019
Start date
Sep 18, 2018
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Sep 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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