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)

StatusCompleted
PhasePhase 1/2
SponsorPfizer
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2026 to Sep 10, 2026
    • Study sites: 21 to 23
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Collaborators: 2 to 3
  2. Primary and study completion dates: Apr 30, 2026 to Dec 31, 2026
    • Study sites revised (21)
    v12
  3. Primary and study completion dates: Nov 4, 2025 to Apr 30, 2026
    • Study sites revised (21)
    v11
  4. Primary and study completion dates: Nov 3, 2025 to Nov 4, 2025v10
  5. Trial status: Recruiting to Active, Not Recruitingv9 Show 4 more changesShow less
    • Enrollment target: estimated 67 to confirmed 11
    • Study sites: 47 to 21
    • Primary completion date: Jul 23, 2026 to Nov 3, 2025
    • Study completion date: Jan 25, 2027 to Nov 3, 2025
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  1. Site details revised at 3 of 47 sitesv8
  2. Study sites: 41 to 47v7
  3. Study sites: 20 to 41v6
  4. Study sites: 11 to 20
    • Primary completion date: Feb 4, 2027 to Jul 23, 2026
    • Study completion date: Aug 9, 2027 to Jan 25, 2027
    v5
  5. Primary completion date: Aug 3, 2026 to Feb 4, 2027
    • Study sites: 6 to 11
    • Study completion date: Feb 2, 2027 to Aug 9, 2027
    v4
  6. Phase: Phase 2 to Phase 1/2
    • Study sites: 5 to 6
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 4 to 5
    • Start date changed from estimate of Nov 10, 2023 to Jan 10, 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
438 trials monitored
See 32 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: * is hard to treat (advanced) and may have spread to other organs (metastatic). is sensitive to hormonal therapy (it is called estrogen receptor positive). * is no longer responding to treatments taken before starting this study. This study is divided into separate sub-studies. For Sub-Study C: All the participants will receive vepdegestrant and a medicine called samuraciclib. Vepdegestrant and samuraciclib will be taken once in a day by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicine is safe and effective. Participant will continue to take vepdegestrant and samuraciclib 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.
Trial Details
NCT Number NCT06125522
Lead Sponsor Pfizer
Collaborators: Arvinas Estrogen Receptor, Inc., Carrick Therapeutics Limited, Rigel Pharmaceuticals,Inc.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov