Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04874025
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2021-04-30
Brief Title:
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced andor Metastatic Breast Cancer
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and or Metastatic RH HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALBOSPAIN
Brief Summary:
Hormone therapy is the primary treatment option for patients with HR HER2- breast cancer Despite its activity hormone therapy is associated with initial or more frequently acquired resistance after exposure to one or more treatment lines
The combination of palbociclib with hormone therapy significantly increases progression free survival PFS compared with hormone therapy in first and second treatment line of HR HER2- advanced breast cancer
These results lead to palbociclib approval by the Food and Drug Administration FDA in February 2015 and European Medicines Agency EMA approval in November 2016 for first-line treatment of patients with metastatic HRHER2-breast cancer in combination with an aromatase inhibitor and for patients who had previously received hormone therapy in combination with fulvestrant
In Spain palbociclib was launched last November 1st 2017 During this period approximately 3500 patients have received treatment with Palbociclib and approximately a half of them in first-line treatment in combination with hormone therapy The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest
The combination of palbociclib with hormone therapy significantly increases progression free survival PFS compared with hormone therapy in first and second treatment line of HR HER2- advanced breast cancer
These results lead to palbociclib approval by the Food and Drug Administration FDA in February 2015 and European Medicines Agency EMA approval in November 2016 for first-line treatment of patients with metastatic HRHER2-breast cancer in combination with an aromatase inhibitor and for patients who had previously received hormone therapy in combination with fulvestrant
In Spain palbociclib was launched last November 1st 2017 During this period approximately 3500 patients have received treatment with Palbociclib and approximately a half of them in first-line treatment in combination with hormone therapy The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None