Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Canada / NCT05548127
Active, not recruiting Phase 1/2

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)

NCT05548127 · tracked via the Priya Life Science Canada tracker
Sponsor
Pfizer
Phase
Phase 1/2
Started
2023-02-23
Last updated
2026-09-02

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

ARV-471 →Abemaciclib →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Phase 1b: number of participants with dose limiting toxicities — 28 days
    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 \[28 days\]).
  • Phase 2: percentage of participants with objective response by investigator assessment — Up to approximately 1 year
    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.

Trial sites (37)

FacilityCityRegionStatus
Stanford Women's Cancer Center Palo Alto California
UCSF Medical Center at Mission Bay San Francisco California
Moffitt Cancer Center - International Plaza Tampa Florida
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center Tampa Florida
Moffitt McKinley Hospital Tampa Florida
Memorial Hospital Shiloh Illinois
Siteman Cancer Center - Shiloh Shiloh Illinois
Siteman Cancer Center - St Peters City of Saint Peters Missouri
Siteman Cancer Center - West County Creve Coeur Missouri
Siteman Cancer Center - North County Florissant Missouri
Siteman Cancer Center St Louis Missouri
Barnes-Jewish Hospital St Louis Missouri
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri
Washington University School of Medicine St Louis Missouri
Siteman Cancer Center - South County St Louis Missouri
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376 Houston Texas
U.T. MD Anderson Cancer Center Houston Texas
University of Texas MD Anderson Cancer Center Houston Texas
Northwest Medical Specialties, PLLC Bonney Lake Washington
Northwest Medical Specialties, PLLC Federal Way Washington
Northwest Medical Specialties, PLLC Gig Harbor Washington
Northwest Medical Specialties, PLLC Puyallup Washington
Northwest Medical Specialties, PLLC Tacoma Washington
BC Cancer Vancouver Vancouver British Columbia
BC Cancer Vancouver Vancouver British Columbia
The Ottawa Hospital - General Campus Ottawa Ontario
Sunnybrook Research Institute Toronto Ontario
CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi Quebec
Jewish General Hospital Montreal Quebec
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Rome Lazio
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia Candiolo Torino
Hospital Universitari Vall d'Hebron Barcelona Barcelona [barcelona]
Hospital Universitari Dexeus Barcelona Catalunya [cataluña]
Clinica Universidad de Navarra Madrid Madrid, Comunidad de
Hospital Universitario 12 de Octubre Madrid Madrid, Comunidad de
Clinica Universidad de Navarra Pamplona Navarre
Hospital Universitario Virgen Del Rocio Seville Spain

On this site

📄 Verzenio (abemaciclib) drug profile →

More Pfizer trials in Canada

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Active, not recruiting
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Active, not recruiting
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies Recruiting
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine Recruiting
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Active, not recruiting

Other trials for the same condition

Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction Recruiting
Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses Recruiting
Pharmacogenomic and Circulating Biomarkers for CDK4/6 Inhibitors Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05548127 on ClinicalTrials.gov ↗ ← All trials in Canada