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Completed

NCT Number: NCT04109261

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fernando Moreno

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Palbociclib

Drug

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

Primary outcomes

  1. Time to progression

    Time frame: through study completion, up to 9 months

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

Secondary outcomes

  1. Number of adverse events

    Time frame: through study completion, up to 9 months

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

Sponsors and collaborators

Lead sponsor

Fernando Moreno Antón

Other

Registry information

Official study title

Retrospective Observational Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programme

Acronym: PALBOCOMP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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