Ignite Creation Date:
2024-05-05 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00777049
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2008-10-21
Brief Title:
Study of Panobinostat Monotherapy in Women With HER2-negative Locally Recurrent or Metastatic Breast Cancer
Sponsor:
Translational Research in Oncology
Organization:
Translational Research in Oncology
Study Overview
Official Title:
A Phase II Open-label Multicenter Trial of Panobinostat Monotherapy in Women With HER2-negative Locally Recurrent or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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:
None
Brief Summary:
The purpose of the study is to assess the benefit of oral panobinostat monotherapy given to women with HER2-negative locally recurrent or metastatic breast cancer
Detailed Description:
This was a phase II open label multi-centre two-arm two-stage design international study of oral panobinostat in women with HER2-negative locally recurrent or metastatic breast cancer
In the first stage of the trial 21 evaluable patients HR ER andor PgR HER2-negative were to be treated Arm I if less than 3 responses were observed that arm would be stopped and the treatment in this patient population would be declared as ineffective In the other arm 27 evaluable patients HR- ER- and PgR- HER2-negative were to be treated Arm II if less than 2 responses were observed that arm would be stopped and the treatment in this patient population would be declared as ineffective
Given these protocol conditions the study was stopped in Arm II due to low recruitment as there was insufficient data available to draw conclusions regarding efficacy in that arm It should also be noted that only one response was observed in this group In Arm I among the 25 evaluable patients the study did not achieve the required number of tumor responses to allow enrolment to continue
As such the protocol was amended to stop enrolment and remove analysis of the initially planned secondary objectives Progression Free Survival and Overall Survival considering the small study sample size The patients already included were given the option to continue in the study until they reached their planned end-of-study visit
In the first stage of the trial 21 evaluable patients HR ER andor PgR HER2-negative were to be treated Arm I if less than 3 responses were observed that arm would be stopped and the treatment in this patient population would be declared as ineffective In the other arm 27 evaluable patients HR- ER- and PgR- HER2-negative were to be treated Arm II if less than 2 responses were observed that arm would be stopped and the treatment in this patient population would be declared as ineffective
Given these protocol conditions the study was stopped in Arm II due to low recruitment as there was insufficient data available to draw conclusions regarding efficacy in that arm It should also be noted that only one response was observed in this group In Arm I among the 25 evaluable patients the study did not achieve the required number of tumor responses to allow enrolment to continue
As such the protocol was amended to stop enrolment and remove analysis of the initially planned secondary objectives Progression Free Survival and Overall Survival considering the small study sample size The patients already included were given the option to continue in the study until they reached their planned end-of-study visit
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