Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02732119
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2016-04-04
Brief Title:
Study of Ribociclib With Everolimus Exemestane in HR HER2- Locally AdvancedMetastatic Breast Cancer Post Progression on CDK 46 Inhibitor
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Single Arm Open-label Study of Ribociclib in Combination With Everolimus Exemestane in the Treatment of Men and Postmenopausal Women With HR HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 46 Inhibitor
Status:
COMPLETED
Status Verified Date:
2021-04
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:
TRINITI-1
Brief Summary:
The purpose of this study is determine if the triplet combination of ribociclib everolimus and exemastane is safe and effective in the treatment of locally advancedmetastatic breast cancer following treatment with a CDK 46 inhibitor
Detailed Description:
This trial had two phases The purpose of Phase I dose escalation and dose de-escalation was to determine the maximum tolerated doses MTDs andor identify the recommended Phase II dose RP2D of the combination treatment of ribociclib everolimus exemestane The dosing was continuous in adult men and postmenopausal women with HR HER2-negative advanced breast cancer which was resistant to the non-steroidal aromatase inhibitors fulvestrant or tamoxifen
The purpose of the phase II portion of this trial was to evaluate the anti-tumor activity of exemestane everolimus and ribociclib combination therapy following progression on a CDK 46 inhibitor
The planned duration of the study was 30 months
The purpose of the phase II portion of this trial was to evaluate the anti-tumor activity of exemestane everolimus and ribociclib combination therapy following progression on a CDK 46 inhibitor
The planned duration of the study was 30 months
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