Breast Cancer Clinical Trial

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)

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 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.

View Full Description

Full Description

C4891023 is a prospective, open-label, multicenter, Phase 1b/2 sub-study to evaluate the safety, antitumor activity, and PK of ARV-471 with ribociclib in the treatment of participants with A/MBC. The sub-study is part of Umbrella platform, TACTIVE-U, comprising multiple sub-studies that independently evaluate ARV-471 in participants with with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Advanced or Metastatic Breast Cancer. ARV-471 will act as the backbone therapy given in combination with other anticancer agents thought to have clinical relevance in ER+ breast cancer.

View Eligibility Criteria

Eligibility Criteria

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, and only 1, line of any CDK4/6 inhibitor-based regimen is required (in any setting eg adjuvant, 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 of 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT05573555

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 37 Locations for this study

See Locations Near You

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
Siteman Cancer Center - WUPI
Shiloh Illinois, 62269, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, 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
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
Houston Area Locations The Woodland
Conroe Texas, 77384, 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
Houston Area Locations MDACC West Houston
Houston Texas, 77079, United States
Houston Area Locations MDACC League City
League City Texas, 77573, United States
Houston Area Locations MDACC Sugarland
Sugar Land Texas, 77478, United States
BC Cancer Vancouver
Vancouver British Columbia, V5Z 1, Canada
BC Cancer Vancouver
Vancouver British Columbia, V5Z 4, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi Quebec, G7H 5, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli Campania, 80131, Italy
Humanitas Istituto Clinico Catanese
Misterbianco Catania, 95045, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma Lazio, 00168, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza Lombardia, 20900, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo Torino, 10060, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona , 60126, Italy
Istituto Oncologico Veneto IRCCS
Padova , 35128, Italy
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [barcelona], 08035, Spain
Hospital Universitari Dexeus
Barcelona Catalunya [cataluña], 08028, Spain
Hospital General Universitario Gregorio Marañon
Madrid Madrid, Comunidad DE, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid Madrid, Comunidad DE, 28041, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT05573555

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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