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 A)
NCT ID: NCT05548127
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
37 participants
INTERVENTIONAL
2023-02-23
2026-03-01
Brief Summary
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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 A:
All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Participants will continue to take ARV-471 and abemaciclib 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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
Phase 2 will further evaluate the preliminary antitumor activity and safety of the combination RP2D.
TREATMENT
NONE
Study Groups
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ARV-471 in combination with Abemaciclib
ARV-471 administered orally once daily (QD) and Abemaciclib orally twice daily (BID) on 28-day cycle
ARV-471
Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b until the recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
Abemaciclib
Daily oral dosages of Abemaciclib continuously, cycles lasting 28 days
Interventions
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ARV-471
Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b until the recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
Abemaciclib
Daily oral dosages of Abemaciclib continuously, cycles lasting 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* prior anticancer therapies: at least 1 and no more than 2 lines of prior therapies for advanced/metastatic disease; 1 line of any CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic)
* at least 1 measurable lesion as defined by RECIST v1.1.
* ECOG PS ≤1.
Exclusion Criteria
* known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
* newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 14 days prior to enrollment in the study.
* history of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix.
* inflammatory breast cancer
* impaired cardiovascular function or clinically significant cardiovascular diseases
* concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong/moderate inducers of CYP3A and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
* renal impairment, not adequate liver function and/or bone marrow function
* known active infection
18 Years
ALL
No
Sponsors
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Arvinas Estrogen Receptor, Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Stanford Women's Cancer Center
Palo Alto, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Moffitt Cancer Center - International Plaza
Tampa, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, United States
Moffitt McKinley Hospital
Tampa, Florida, United States
Siteman Cancer Center - WUPI
Shiloh, Illinois, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376
Houston, Texas, United States
U.T. MD Anderson Cancer Center
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
BC Cancer Vancouver
Vancouver, British Columbia, Canada
BC Cancer Vancouver
Vancouver, British Columbia, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Dexeus
Barcelona, Catalunya [cataluña], Spain
Clinica Universidad de Navarra
Madrid, Madrid, Comunidad de, Spain
Clínica Universidad de Navarra
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-502228-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4891006
Identifier Type: -
Identifier Source: org_study_id
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