Fact CheckerSign in

NCT05548127Active, not recruitingPhase 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)

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)

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
37 (actual)
First submitted
25 Aug 2022
Start date
23 Feb 2023
Primary completion date
24 Mar 2027
Lead sponsor
Pfizer
NCT number
NCT05548127
EU CT number
2022-502228-34-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 37
  • From 23 Feb 2023 to the primary completion date, 24 Mar 2027
  • 35 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
  • 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
  • renal impairment, not adequate liver function and/or bone marrow function
  • known active infection

Lab values

  • 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.

Other

  • visceral crisis at risk of life-threatening complications in the short term

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIUSSS- saguenay-Lac-Saint-Jean
Coordinator of this site? Confirm its status
ChicoutimiCanadaUnknown status
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
The Ottawa Hospital - General Campus
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Sunnybrook Research Institute
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
BC Cancer - Vancouver
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital Universitari Dexeus Grupo Quironsalud
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Clinica Universidad de Navarra
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Coordinator of this site? Confirm its status
CandioloItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Northwest Medical Specialties, PLLC
Coordinator of this site? Confirm its status
Bonney LakeUnited StatesUnknown status
Siteman Cancer Center - St Peters
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesUnknown status
Siteman Cancer Center - West County
Coordinator of this site? Confirm its status
Creve CoeurUnited StatesUnknown status
Northwest Medical Specialties, PLLC
Coordinator of this site? Confirm its status
Federal WayUnited StatesUnknown status
Siteman Cancer Center - North County
Coordinator of this site? Confirm its status
FlorissantUnited StatesUnknown status
Northwest Medical Specialties, PLLC
Coordinator of this site? Confirm its status
Gig HarborUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
U.T. MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Stanford Women's Cancer Center
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
NorthWest Medical Specialties, PLLC
Coordinator of this site? Confirm its status
PuyallupUnited StatesUnknown status
UCSF Medical Center at Mission Bay
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Siteman Cancer Center - Shiloh
Coordinator of this site? Confirm its status
ShilohUnited StatesUnknown status
Memorial Hospital
Coordinator of this site? Confirm its status
ShilohUnited StatesUnknown status
Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Barnes-Jewish Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Siteman Cancer Center-South County
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Northwest Medical Specialties PLLC
Coordinator of this site? Confirm its status
TacomaUnited StatesUnknown status
Moffitt Cancer Center-International Plaza
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Moffitt McKinley Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.