Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05654623
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2022-11-16
Brief Title:
A Study to Learn About a New Medicine Called Vepdegestrant ARV-471 PF-07850327 in People Who Have Advanced Metastatic Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 3 RANDOMIZED OPEN-LABEL MULTICENTER TRIAL OF ARV-471 PF-07850327 VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE VERITAC-2
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:
VERITAC-2
Brief Summary:
A study to learn about a new medicine called ARV-471 PF-07850327 in people who have advanced metastatic breast cancer
Detailed Description:
The purpose of this study is to learn about the safety and effects of the study medicine ARV-471 PF-07850327 vepdegestrant compared to fulvestrant FUL in participants with advanced breast cancer Advanced breast cancer is difficult to cure or control with treatment The cancer may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body ie bones lungs brain or liver FUL is a medicine already used for treatment of breast cancer while ARV-471 is a new medicine
This study is seeking participants with breast cancer who
have cancer that has come back in the place where it started or spread to nearby tissue lymph nodes or distant parts of the body
cannot be fully cured by surgery or radiation therapy Radiation therapy is the use of high-energy radiation such as x-rays gamma rays and other sources to kill cancer cells and shrink tumors
respond to hormonal or endocrine therapy which target hormones andor activity of hormone receptors such as tamoxifen or aromatase inhibitors this is called estrogen receptor positive disease
have received one line of CDK46 inhibitor therapy for example palbociclib ribociclib or abemaciclib in combination with endocrine therapy for example letrozole for advanced cancer
are allowed up to one other endocrine therapy for example exemestane for advanced cancer
Half of the participants will be given ARV-471 while the other half of the participants will be given FUL
Participants who get ARV-471 will take ARV-471 by mouth with food one time a day During the first treatment cycle participants who will get FUL will be given FUL by shots into the muscles on Day 1 and again 2 weeks later After the first month FUL shots will be given on the first day of each new treatment cycle One treatment cycle is 28 days
Participants will receive the study medicine until their breast cancer worsens or side effects become too severe Participants will have visits at the study clinic about every 4 weeks
This study is seeking participants with breast cancer who
have cancer that has come back in the place where it started or spread to nearby tissue lymph nodes or distant parts of the body
cannot be fully cured by surgery or radiation therapy Radiation therapy is the use of high-energy radiation such as x-rays gamma rays and other sources to kill cancer cells and shrink tumors
respond to hormonal or endocrine therapy which target hormones andor activity of hormone receptors such as tamoxifen or aromatase inhibitors this is called estrogen receptor positive disease
have received one line of CDK46 inhibitor therapy for example palbociclib ribociclib or abemaciclib in combination with endocrine therapy for example letrozole for advanced cancer
are allowed up to one other endocrine therapy for example exemestane for advanced cancer
Half of the participants will be given ARV-471 while the other half of the participants will be given FUL
Participants who get ARV-471 will take ARV-471 by mouth with food one time a day During the first treatment cycle participants who will get FUL will be given FUL by shots into the muscles on Day 1 and again 2 weeks later After the first month FUL shots will be given on the first day of each new treatment cycle One treatment cycle is 28 days
Participants will receive the study medicine until their breast cancer worsens or side effects become too severe Participants will have visits at the study clinic about every 4 weeks
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 |
|---|---|---|---|
| 2022-500544-38-00 | REGISTRY | CTIS EU | None |