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

NCT04109261 | Completed

• 1 other identifier: PALBOCOMP
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

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

  through study completion, up to 9 months

Secondary Outcomes (1)

• Number of adverse events

  through study completion, up to 9 months

Study Arms (1)

Palbociclib treatment

Drug: Palbociclib

Interventions

Palbociclib DRUG

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

Palbociclib treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic breast cancer included in a compassionate use programme

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fernando Moreno Antón: lead

Study Sites (1)

Fernando Moreno

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: September 30, 2019
• Study Start: September 18, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

ES (1)