Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04964934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2021-06-30
Brief Title:
Phase III Study to Assess AZD9833 CDK46 Inhibitor in HRHER2-MBC With Detectable ESR1m Before Progression SERENA-6
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Double-blind Randomised Study to Assess Switching to AZD9833 a Next Generation Oral SERD CDK46 Inhibitor vs Continuing Aromatase Inhibitor Letrozole or Anastrozole CDK46 Inhibitor in HRHER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor CDK46 Inhibitor- A ctDNA Guided Early Switch Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
SERENA-6
Brief Summary:
The study is intended to show superiority of AZD9833 in combination with CDK46 inhibitor palbociclib abemaciclib or ribociclib versus aromatase inhibitors anastrozole or letrozole in combination with CDK46 inhibitor in patients with hormone receptor-positive HR-positive human epidermal growth factor receptor 2-negative HER2-negative metastatic breast cancer with detectable ESR1 mutation
Detailed Description:
Breast cancer is the most common type of cancer among women In people with breast cancer the body is not able to control the growth of some cells These extra cells can form tumors in the breast When tumor cells move to different parts of the body this is called advanced cancer Researchers are looking for better ways to treat advanced breast cancer
This trial will look at six drugs palbociclib abemaciclib ribociclib letrozole anastrozole and AZD9833 AZD9833 is the trial drug and is the only drug not yet approved for use Palbociclib abemaciclib and ribociclib work in the same way and are a type of cancer drug called a CDK46 inhibitor Letrozole and anastrozole work in the same way and are both a type of cancer drug called an aromatase inhibitor AI CDK46 inhibitors and AIs work together to block the tumors ability to grow These drugs have been approved for combined use in people with advanced breast cancer that is HR-positive and HER2-negative But if people get mutations in the ESR1 gene it can make the AI and CDK46 inhibitor treatment work less well
The trial drug AZD9833 is designed to work with a CDK46 inhibitor in the same way that an AI does Researchers think that AZD9833 might work better with a CDK46 inhibitor than an AI does in people who get mutations in their ESR1 gene
Participants in this trial will have already been receiving one of the following combinations of a CDK46 inhibitor and an AI
palbociclib anastrozole
palbociclib letrozole
abemaciclib anastrozole
abemaciclib letrozole
ribociclib anastrozole
ribociclib letrozole
During the trial participants will remain on the same CDK46 inhibitor that they were taking before the trial
In this trial the researchers want to find out how well switching a participant with an ESR1 gene mutation from an AI letrozole or anastrozole to AZD9833 works in the treatment of advanced breast cancer that is HR-positive and HER2-negative
The researchers will look at which trial treatment helps the participants live longer with the cancer before it gets worse
The researchers also want to know more about how safe AZD9833 is
The trial participants will be split into 2 groups
Participants in Group A will receive AZD9833 a CDK46 inhibitor and a placebo
Participants in Group B will receive an AI a CDK46 inhibitor and a placebo
A placebo looks like a treatment but does not have any medicine in it
A computer program will be used to randomly choose the treatments each participant gets This helps make sure the groups are chosen fairly Researchers do this so that comparing the results of each treatment will be as accurate as possible
The participants will take their trial treatments over 28-day cycles with a placebo and either AZD9833 or an AI taken once daily by mouth for all 28 days If the participant is taking abemaciclib they will take it twice daily by mouth for all 28 days If the participant is taking palbociclib or ribociclib they will take it once daily by mouth for 21 days and then stop taking it for the final 7 days of the cycle The participant will then repeat the 28-day cycle receiving the trial treatment in the same way for as long as they are in the trial
Participants will visit their trial site regularly throughout the trial At these visits the trial doctors will check the health of the participants They will also take blood samples and do scans of the participants tumors
Participants will take their trial treatment until their cancer gets worse or they decide to leave the trial
Palbociclib and Abemacliclib cohorts are currently ongoing Ribociclib cohort will be open pending on availability of the data
This trial will look at six drugs palbociclib abemaciclib ribociclib letrozole anastrozole and AZD9833 AZD9833 is the trial drug and is the only drug not yet approved for use Palbociclib abemaciclib and ribociclib work in the same way and are a type of cancer drug called a CDK46 inhibitor Letrozole and anastrozole work in the same way and are both a type of cancer drug called an aromatase inhibitor AI CDK46 inhibitors and AIs work together to block the tumors ability to grow These drugs have been approved for combined use in people with advanced breast cancer that is HR-positive and HER2-negative But if people get mutations in the ESR1 gene it can make the AI and CDK46 inhibitor treatment work less well
The trial drug AZD9833 is designed to work with a CDK46 inhibitor in the same way that an AI does Researchers think that AZD9833 might work better with a CDK46 inhibitor than an AI does in people who get mutations in their ESR1 gene
Participants in this trial will have already been receiving one of the following combinations of a CDK46 inhibitor and an AI
palbociclib anastrozole
palbociclib letrozole
abemaciclib anastrozole
abemaciclib letrozole
ribociclib anastrozole
ribociclib letrozole
During the trial participants will remain on the same CDK46 inhibitor that they were taking before the trial
In this trial the researchers want to find out how well switching a participant with an ESR1 gene mutation from an AI letrozole or anastrozole to AZD9833 works in the treatment of advanced breast cancer that is HR-positive and HER2-negative
The researchers will look at which trial treatment helps the participants live longer with the cancer before it gets worse
The researchers also want to know more about how safe AZD9833 is
The trial participants will be split into 2 groups
Participants in Group A will receive AZD9833 a CDK46 inhibitor and a placebo
Participants in Group B will receive an AI a CDK46 inhibitor and a placebo
A placebo looks like a treatment but does not have any medicine in it
A computer program will be used to randomly choose the treatments each participant gets This helps make sure the groups are chosen fairly Researchers do this so that comparing the results of each treatment will be as accurate as possible
The participants will take their trial treatments over 28-day cycles with a placebo and either AZD9833 or an AI taken once daily by mouth for all 28 days If the participant is taking abemaciclib they will take it twice daily by mouth for all 28 days If the participant is taking palbociclib or ribociclib they will take it once daily by mouth for 21 days and then stop taking it for the final 7 days of the cycle The participant will then repeat the 28-day cycle receiving the trial treatment in the same way for as long as they are in the trial
Participants will visit their trial site regularly throughout the trial At these visits the trial doctors will check the health of the participants They will also take blood samples and do scans of the participants tumors
Participants will take their trial treatment until their cancer gets worse or they decide to leave the trial
Palbociclib and Abemacliclib cohorts are currently ongoing Ribociclib cohort will be open pending on availability of the data
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 |
|---|---|---|---|
| 2023-503990-39-00 | OTHER | None | None |
| 2021-000546-17 | EUDRACT_NUMBER | EU CT number | None |