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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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05573555
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Canada, Italy, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Breast Cancer
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: ARV-471 in combination with Ribociclib

ARV-471 administered orally QD continuously and Ribociclib administered orally QD consecutively for 21 days followed by 7 days off treatment on 28-day cycles

Interventions

Drug: - ARV-471

Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b until RP2D determined, cycles lasting 28 days

Drug: - Ribociclib

Daily oral dosages of ribociclib consecutively for 21 days followed by 7 days off treatment, cycles lasting 28 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Women's Cancer Center, Palo Alto, California

Status

Recruiting

Address

Stanford Women's Cancer Center

Palo Alto, California, 94304

UCSF Medical Center at Mission Bay, San Francisco, California

Status

Recruiting

Address

UCSF Medical Center at Mission Bay

San Francisco, California, 94158

Tampa, Florida

Status

Not yet recruiting

Address

Moffitt Cancer Center - International Plaza

Tampa, Florida, 33607

Tampa, Florida

Status

Not yet recruiting

Address

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, 33612

Moffitt Cancer Center, Tampa, Florida

Status

Not yet recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Siteman Cancer Center - WUPI, Shiloh, Illinois

Status

Recruiting

Address

Siteman Cancer Center - WUPI

Shiloh, Illinois, 62269

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Brigham and Women's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Not yet recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Newton, Massachusetts

Status

Not yet recruiting

Address

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, 02459

Siteman Cancer Center - West County, Creve Coeur, Missouri

Status

Recruiting

Address

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141

Siteman Cancer Center - North County, Florissant, Missouri

Status

Recruiting

Address

Siteman Cancer Center - North County

Florissant, Missouri, 63031

Saint Louis, Missouri

Status

Recruiting

Address

Barnes Jewish Hospital Department of Laboratories

Saint Louis, Missouri, 63110

Barnes-Jewish Hospital, Saint Louis, Missouri

Status

Recruiting

Address

Barnes-Jewish Hospital

Saint Louis, Missouri, 63110

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, 63110

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Barnes Jewish Hospital Lab- South County, Saint Louis, Missouri

Status

Recruiting

Address

Barnes Jewish Hospital Lab- South County

Saint Louis, Missouri, 63129

Siteman Cancer Center - South County, Saint Louis, Missouri

Status

Recruiting

Address

Siteman Cancer Center - South County

Saint Louis, Missouri, 63129

Siteman Cancer Center - St Peters, Saint Peters, Missouri

Status

Recruiting

Address

Siteman Cancer Center - St Peters

Saint Peters, Missouri, 63376

Houston Area Locations The Woodland, Conroe, Texas

Status

Recruiting

Address

Houston Area Locations The Woodland

Conroe, Texas, 77384

Houston, Texas

Status

Recruiting

Address

U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376

Houston, Texas, 77030

U.T. MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

U.T. MD Anderson Cancer Center

Houston, Texas, 77030

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Houston, Texas

Status

Recruiting

Address

Houston Area Locations MDACC West Houston

Houston, Texas, 77079

Houston Area Locations MDACC League City, League City, Texas

Status

Recruiting

Address

Houston Area Locations MDACC League City

League City, Texas, 77573

Houston Area Locations MDACC Sugarland, Sugar Land, Texas

Status

Recruiting

Address

Houston Area Locations MDACC Sugarland

Sugar Land, Texas, 77478

International Sites

BC Cancer Vancouver, Vancouver, British Columbia, Canada

Status

Recruiting

Address

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 1H7

BC Cancer Vancouver, Vancouver, British Columbia, Canada

Status

Recruiting

Address

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6

The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

Status

Recruiting

Address

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6

Sunnybrook Research Institute, Toronto, Ontario, Canada

Status

Recruiting

Address

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5

CIUSSS- saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, Canada

Status

Recruiting

Address

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, G7H 5H6

Jewish General Hospital, Montreal, Quebec, Canada

Status

Recruiting

Address

Jewish General Hospital

Montreal, Quebec, H3T 1E2

Napoli, Campania, Italy

Status

Not yet recruiting

Address

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, Campania, 80131

Humanitas Istituto Clinico Catanese, Misterbianco, Catania, Italy

Status

Not yet recruiting

Address

Humanitas Istituto Clinico Catanese

Misterbianco, Catania, 95045

Roma, Lazio, Italy

Status

Not yet recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Lazio, 00168

Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardia, 20900

Candiolo, Torino, Italy

Status

Not yet recruiting

Address

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

Candiolo, Torino, 10060

Ancona, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero Universitaria delle Marche

Ancona, , 60126

Istituto Oncologico Veneto IRCCS, Padova, Italy

Status

Not yet recruiting

Address

Istituto Oncologico Veneto IRCCS

Padova, , 35128

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035

Hospital Universitari Dexeus, Barcelona, Catalunya [cataluña], Spain

Status

Not yet recruiting

Address

Hospital Universitari Dexeus

Barcelona, Catalunya [cataluña], 08028

Madrid, Madrid, Comunidad DE, Spain

Status

Not yet recruiting

Address

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad DE, 28009

Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad DE, Spain

Status

Not yet recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad DE, 28041

Hospital Universitario Virgen Del Rocio, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Del Rocio

Sevilla, , 41013

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