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)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Pfizer
Study ID
NCT05573555
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARV-471 — DRUG
    Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b until RP2D determined, cycles lasting 28 days
  • Ribociclib — DRUG
    Daily oral dosages of ribociclib consecutively for 21 days followed by 7 days off treatment, cycles lasting 28 days

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ARV-471 in combination with Ribociclib
    ARV-471 administered orally QD continuously and Ribociclib administered orally QD consecutively for 21 days followed by 7 days off treatment on 28-day cycles

Primary Outcome Measure

Phase 1b: Number of Participants With Dose Limiting Toxicities [ Time Frame: Cycle 1 (28 days) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Stanford Women's Cancer CenterPalo AltoCalifornia94304-
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158-
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center - International PlazaTampaFlorida33607-
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient CenterTampaFlorida33612-
Moffitt McKinley HospitalTampaFlorida33612-
Siteman Cancer Center - WUPIShilohIllinois62269-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber Cancer Institute - Chestnut HillNewtonMassachusetts02459-
Siteman Cancer Center - St PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
Siteman Cancer Center - North CountyFlorissantMissouri63031-
Barnes Jewish Hospital Department of LaboratoriesSt LouisMissouri63110-
Barnes Jewish Hospital Lab- South CountySt LouisMissouri63129-
Barnes-Jewish HospitalSt LouisMissouri63110-
Siteman Cancer CenterSt LouisMissouri63108-
Siteman Cancer Center - South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110-

Find similar trials in Palo Alto, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Stanford Women's Cancer Center· Palo Alto, CAUCSF Medical Center at Mission Bay· San Francisco, CAMoffitt Cancer Center· Tampa, FLMoffitt Cancer Center - International Plaza· Tampa, FLMoffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center· Tampa, FLMoffitt McKinley Hospital· Tampa, FL

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