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

Breast Cancer Clinical Trial

— PALBOCOMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109261
• Other study ID #: PALBOCOMP
• Status: Completed
• Start date: September 18, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Fernando Moreno	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fernando Moreno Antón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of adverse events	Number of adverse events between the beginning of the treatment with palbociclib and the progression	through study completion, up to 9 months