Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06105632
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-10-24
Brief Title:
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN INTERVENTIONAL OPEN-LABEL RANDOMIZED MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATORS CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE HER2-NEGATIVE ADVANCEDMETASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 46 INHIBITOR-BASED THERAPY
Status:
RECRUITING
Status Verified Date:
2024-10
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 this study is to learn about the safety and how effective the study medicine PF-07220060 plus fulvestrant is compared to the study doctors choice of treatment in people with advanced or metastatic breast cancer Advanced cancer is the one that is unlikely to be cured or taken care of with treatment Metastatic cancer is the one that has spread to other parts of the body
This study is seeking female and male participants who
are 18 years of age or older
are hormone receptor HR-positive and human epidermal growth factor receptor 2 HER2-negative
have advanced or metastatic breast cancer after taking other treatments before this study
have not taken or need to take medications that are not allowed by the study protocol
do not have any medical or mental conditions that may increase the risk of study participation
Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant Fulvestrant will be given as a shot into the muscle The other half will take the study doctors choice of treatment which can either be
Fulvestrant alone taken as shot into the muscle
Everolimus along with exemestane taken once daily by mouth
This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctors choice of treatment This will help decide if the study medicine is safe and effective
Participants will receive study treatment andor will be in the study until
imaging scans such as an MRI andor CT show that their cancer is getting worse
the study doctor thinks the participant is no longer benefitting from the study medicine
has side effects that become too severe A side effect is a reaction expected or unexpected to a medicine or treatment you take
the participant chooses to stop taking part
This study is seeking female and male participants who
are 18 years of age or older
are hormone receptor HR-positive and human epidermal growth factor receptor 2 HER2-negative
have advanced or metastatic breast cancer after taking other treatments before this study
have not taken or need to take medications that are not allowed by the study protocol
do not have any medical or mental conditions that may increase the risk of study participation
Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant Fulvestrant will be given as a shot into the muscle The other half will take the study doctors choice of treatment which can either be
Fulvestrant alone taken as shot into the muscle
Everolimus along with exemestane taken once daily by mouth
This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctors choice of treatment This will help decide if the study medicine is safe and effective
Participants will receive study treatment andor will be in the study until
imaging scans such as an MRI andor CT show that their cancer is getting worse
the study doctor thinks the participant is no longer benefitting from the study medicine
has side effects that become too severe A side effect is a reaction expected or unexpected to a medicine or treatment you take
the participant chooses to stop taking part
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-506487-13-00 | REGISTRY | CTIS EU | None |