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 C)
← catalyst calendarNCT06125522 · readout in 134 d
Sponsored by Pfizer (industry) · PFE — their whole pipeline →. With Arvinas Estrogen Receptor, Inc., Carrick Therapeutics Limited.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
11actual
Sites
21
Countries
Belgium, France, Italy +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-01-10 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: vepdegestrant — also filed as ARV-471 / PF-07850327
- Drug: Samuraciclib
Primary outcomes
what the primary-completion date above is the date OFPhase 1b: Number of Participants With Dose Limiting Toxicities
measured 28 days
Drug Drug Interaction: To evaluate the effect of samuraciclib on PK of ARV 471.
measured From the start of Lead-in period (maximum 13 days) to the end of cycle 1 (at least 28 days)
Drug Drug Interaction: To evaluate the effect of samuraciclib on PK of ARV 471.
measured From the start of Lead-in period (maximum 13 days) to the end of cycle 1 (at least 28 days)
Phase 2: Percentage of Participants With Objective Response by investigator assessment
measured Up to approximately 1 year
Drug Drug Interaction: • To evaluate the effect of ARV 471 on PK of samuraciclib.
measured From the start of Lead-in period (maximum 13 days) to the end of cycle 1 (at least 28 days))
Drug Drug Interaction: • To evaluate the effect of ARV 471 on PK of samuraciclib.
measured From the start of Lead-in period (maximum 13 days) to the end of cycle 1 (at least 28 days))
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