Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862663
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2021-03-17
Brief Title:
Capivasertib CDK46i Fulvestrant for AdvancedMetastatic HRHER2- Breast Cancer CAPItello-292
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase IbIII Open-label Randomised Study of Capivasertib Plus CDK46 Inhibitors and Fulvestrant Versus CDK46 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced Unresectable or Metastatic Breast Cancer CAPItello-292
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPItello-292
Brief Summary:
A Phase IbIII Open-label Randomised Study of Capivasertib plus CDK46 Inhibitors and Fulvestrant versus CDK46 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced Unresectable or Metastatic Breast Cancer CAPItello-292
Detailed Description:
This Phase IbIII study CAPItello-292 aims to evaluate the efficacy safety and the degree of added benefit of capivasertib combined with CDK46i and fulvestrant in participants with locally advanced inoperable or metastatic HRHER2- breast cancer Although the dosing regimens of capivasertib fulvestrant and of CDK46i fulvestrant are established separately the dose and schedule for the triplet combinations capivasertib CDK46i fulvestrant need to be confirmed Therefore the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses RP3D of the triplet combinations The Phase III part of the study will evaluate the efficacy safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigators choice of CDK46i either palbociclib or ribociclib at safe and tolerable doses once identified in comparison with a control arm fulvestrant investigators choice of CDK46i palbociclib or ribociclib in a ER HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004637-20 | EUDRACT_NUMBER | None | None |