ACTIVE_NOT_RECRUITING

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 B)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 B: All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and ribociclib will be given at the same time by mouth, at home, 1 time a day. The experiences of people receiving the study medicine will be examined. This will help determine if the study medicine is safe and effective. Participants will continue to take ARV-471 and ribociclib 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.

Official Title

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 B (ARV-471 IN COMBINATION WITH RIBOCICLIB)

Quick Facts

Study Start:2023-03-01
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05573555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * prior anticancer therapies: at least 1 and no more than 2 lines of prior therapies for advanced/metastatic disease; 1, and only 1, line of any CDK4/6 inhibitor-based regimen is required (in any setting eg adjuvant, metastatic)
  3. * at least 1 measurable lesion as defined by RECIST v1.1.
  4. * ECOG PS ≤1.
  1. * visceral crisis at risk of life-threatening complications in the short term
  2. * known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
  3. * 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 of study.
  4. * 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.
  5. * inflammatory breast cancer
  6. * impaired cardiovascular function or clinically significant cardiovascular diseases
  7. * 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.
  8. * renal impairment, not adequate liver function and/or bone marrow function
  9. * known active infection

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

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 Cancer Center
Tampa, Florida, 33612
United States
Moffitt McKinley Hospital
Tampa, Florida, 33612
United States
Siteman Cancer Center - WUPI
Shiloh, Illinois, 62269
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459
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
Saint Louis, Missouri, 63108
United States
Barnes Jewish Hospital Department of Laboratories
Saint Louis, Missouri, 63110
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Barnes Jewish Hospital Lab- South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center - South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center - St Peters
Saint Peters, Missouri, 63376
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • TACTIVE-U; Umbrella study; PROTAC; metastatic breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer