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NCT05573555 · ClinicalTrials.gov registry record · Phase 1
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)
A Phase 1 study of Breast Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT05573555: Active Phase 1 study of Breast Cancer, sponsored by Pfizer.
NCT05573555 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05573555, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); and * is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study B: All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and ribociclib will be given at the same time by mouth, at home, 1 time a day. The experiences of people receiving the study medicine will be examined. This will help determine if the study medicine is safe and effective. Participants will continue to take ARV-471 and ribociclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.
Primary Outcome
Dose Limiting Toxicities rate for ARV-471 in combination with Ribociclib, estimated based on data from DLT-evaluable participants during the DLT observation period (Cycle 1 \[28 days\]).
Conditions Studied
Interventions
- DRUG Ribociclib
- DRUG ARV-471
Study Locations (20)
Missouri
- Siteman Cancer Center - St Peters - City of Saint Peters
- Siteman Cancer Center - West County - Creve Coeur
- Siteman Cancer Center - North County - Florissant
- Siteman Cancer Center - St Louis
- Barnes Jewish Hospital Department of Laboratories - St Louis
- Barnes-Jewish Hospital - St Louis
- Washington University School of Medicine - Siteman Cancer Center - St Louis
- Washington University School of Medicine - St Louis
- Barnes Jewish Hospital Lab- South County - St Louis
- Siteman Cancer Center - South County - St Louis
Florida
- Moffitt Cancer Center - International Plaza - Tampa
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center - Tampa
- Moffitt Cancer Center - Tampa
- Moffitt McKinley Hospital - Tampa
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Dana-Farber Cancer Institute - Chestnut Hill - Newton
California
- Stanford Women's Cancer Center - Palo Alto
- UCSF Medical Center at Mission Bay - San Francisco
Illinois
- Siteman Cancer Center - WUPI - Shiloh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 1 |
What the registry record for NCT05573555 still lists
NCT05573555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ribociclib is the first listed.
NCT05573555 names 20 study sites across 5 states, led by Missouri, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05573555 about?
NCT05573555 is a clinical study titled "TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)". The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is adva...
What is the current status of trial NCT05573555?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-03-01. Estimated completion is 2026-12-30.
What conditions does trial NCT05573555 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05573555?
The interventions under investigation include: Ribociclib (DRUG), ARV-471 (DRUG).
Who is sponsoring clinical trial NCT05573555?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05573555 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05573555's enrollment target sits among peer trials
20 1079th of 1224 higher than 112 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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