A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. (VERITAC-2)
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ClinicalTrials.gov Identifier: NCT05654623 |
Recruitment Status :
Recruiting
First Posted : December 16, 2022
Last Update Posted : April 25, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 16, 2022 | ||||||
First Posted Date ICMJE | December 16, 2022 | ||||||
Last Update Posted Date | April 25, 2024 | ||||||
Actual Study Start Date ICMJE | March 3, 2023 | ||||||
Estimated Primary Completion Date | August 14, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: From randomization date (every 8 weeks for the first 48 weeks and then every 12 weeks thereafter) to date of first documentation of progression OR death (approximately 2 years). ] Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. | ||||||
Official Title ICMJE | 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) | ||||||
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, i.e. 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:
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Breast Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
560 | ||||||
Original Estimated Enrollment ICMJE |
561 | ||||||
Estimated Study Completion Date ICMJE | May 15, 2028 | ||||||
Estimated Primary Completion Date | August 14, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Puerto Rico, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05654623 | ||||||
Other Study ID Numbers ICMJE | C4891001 2022-500544-38-00 ( Registry Identifier: CTIS (EU) ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Pfizer | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Pfizer | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Arvinas Estrogen Receptor, Inc. | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |