Ignite Creation Date:
2024-05-06 @ 8:14 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02692755
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2016-02-23
Brief Title:
Palbociclib Letrozole or Fulvestrant in African American Women With HR HER2- Breast Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-08
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:
PALINA
Brief Summary:
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia
Detailed Description:
The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia A completion rate of 80 is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60 is considered poor and to justify additional safety studies A two stage design with a total of 35 patients is used to test if the completion rate is at least 80 versus if it is below 60 with 80 power at a significance level of 5
An exact confidence interval of the completion rate will be calculated Investigators estimate there will be no more than a 10 rate of febrile neutropenia Due to the small sample size the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing
An exact confidence interval of the completion rate will be calculated Investigators estimate there will be no more than a 10 rate of febrile neutropenia Due to the small sample size the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None