Analysis of Palbociclib Treatment in Patients With Advanc... | NCT04109261

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

NCT04109261

Sponsor

Fernando Moreno Antón

Status

Completed

Last Update Posted

Sep 30, 2019Actual

Enrollment

237Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Palbociclib

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2018Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Sep 27, 2019

First Posted Date

Sep 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2019

Last Update Posted Date

Sep 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

237Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palbociclib treatment			Drug: Palbociclib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic breast cancer included in a compassionate use programme

Sampling Method

Non-Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases