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)
TACTIVE-U: An Interventional Safety and Efficacy Phase 1b/2, Open-label Umbrella Study to Investigate Tolerability, pk, and Antitumor Activity of Vepdegestrant (ARV-471/PF-07850327), an Oral Proteolysis Targeting Chimera, in Combination With Other Anticancer Treatments in Participants Aged 18 Years and Over With ER+ Advanced or Metastatic Breast Cancer, Sub-study A (ARV-471 in Combination With Abemaciclib)
2 other identifiers
interventional
37
4 countries
39
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Feb 2023
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
February 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 10, 2026
February 1, 2026
3.5 years
August 25, 2022
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1b: number of participants with dose limiting toxicities
Dose Limiting Toxicities rate for ARV-471 in combination with abemaciclib, estimated based on data from DLT-evaluable participants during the DLT observation period (Cycle 1 \[28 days\]).
28 days
Phase 2: percentage of participants with objective response by investigator assessment
Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. as determined by investigator assessment.
Up to approximately 1 year
Secondary Outcomes (13)
Phase 1b and Phase 2: number of participants experiencing any AE, SAE, Treatment Related SAE
Up to 28 days after last dose of study treatment
Phase 1b and Phase 2: number of participants with lab abnormalities - Hematology and coagulation parameters
Up to 28 days after last dose of study treatment
Phase 1b and Phase 2: number of participants with lab abnormalities - chemistry parameters
Up to 28 days after last dose of study treatment
Phase 1b: percentage of participants with objective response by investigator assessment
Up to approximately 1 year
Phase 1b and Phase 2: duration of response by investigator assessment.
Up to approximately 3 years
- +8 more secondary outcomes
Study Arms (1)
ARV-471 in combination with Abemaciclib
EXPERIMENTALARV-471 administered orally once daily (QD) and Abemaciclib orally twice daily (BID) on 28-day cycle
Interventions
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
Daily oral dosages of Abemaciclib continuously, cycles lasting 28 days
Eligibility Criteria
You may qualify if:
- histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast cancer that is not amendable to surgical resection with curative intent (≥1% ER+ stained cells on the most recent tumor biopsy).
- 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.
You may not qualify if:
- visceral crisis at risk of life-threatening complications in the short term
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Arvinas Estrogen Receptor, Inc.collaborator
Study Sites (39)
Stanford Women's Cancer Center
Palo Alto, California, 94304, United States
UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
Moffitt Cancer Center - International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612, United States
Moffitt McKinley Hospital
Tampa, Florida, 33612, United States
Memorial Hospital
Shiloh, Illinois, 62269, United States
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269, United States
Siteman Cancer Center - WUPI
Shiloh, Illinois, 62269, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center - North County
Florissant, Missouri, 63031, United States
Siteman Cancer Center
St Louis, Missouri, 63108, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376
Houston, Texas, 77030, United States
U.T. MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, 98391, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, 98003, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, 98332, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 1H7, Canada
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitari Dexeus
Barcelona, Catalunya [cataluña], 08028, Spain
Clinica Universidad de Navarra
Madrid, Madrid, Comunidad de, 28027, Spain
Clínica Universidad de Navarra
Madrid, Madrid, Comunidad de, 28027, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2022
First Posted
September 21, 2022
Study Start
February 23, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.