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
- Diseases
- Metastatic breast cancer
- 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
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIUSSS- saguenay-Lac-Saint-Jean Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital - General Campus Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Cancer - Vancouver Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Dexeus Grupo Quironsalud Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Northwest Medical Specialties, PLLC Coordinator of this site? Confirm its status | Bonney Lake | United States | Unknown status |
| Siteman Cancer Center - St Peters Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Siteman Cancer Center - West County Coordinator of this site? Confirm its status | Creve Coeur | United States | Unknown status |
| Northwest Medical Specialties, PLLC Coordinator of this site? Confirm its status | Federal Way | United States | Unknown status |
| Siteman Cancer Center - North County Coordinator of this site? Confirm its status | Florissant | United States | Unknown status |
| Northwest Medical Specialties, PLLC Coordinator of this site? Confirm its status | Gig Harbor | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| U.T. MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Stanford Women's Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| NorthWest Medical Specialties, PLLC Coordinator of this site? Confirm its status | Puyallup | United States | Unknown status |
| UCSF Medical Center at Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Siteman Cancer Center - Shiloh Coordinator of this site? Confirm its status | Shiloh | United States | Unknown status |
| Memorial Hospital Coordinator of this site? Confirm its status | Shiloh | United States | Unknown status |
| Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine - Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Northwest Medical Specialties PLLC Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Moffitt Cancer Center-International Plaza Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Moffitt McKinley Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.