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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 C)

Study Purpose

The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that:

  • - is hard to treat (advanced) and may have spread to other organs (metastatic).
is sensitive to hormonal therapy (it is called estrogen receptor positive).
  • - is no longer responding to treatments taken before starting this study.
This study is divided into separate sub-studies. For Sub-Study C: All the participants will receive vepdegestrant and a medicine called samuraciclib. Vepdegestrant and samuraciclib will be taken once in a day by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicine is safe and effective. Participant will continue to take vepdegestrant and samuraciclib 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 breast cancer.
At time of enrollment this must not be amendable to surgical resection with curative intent (≥1% ER+ stained cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or in-situ hybridization per ASCO/CAP).
  • - prior anticancer therapies: up to 2 lines of prior therapies for advanced/metastatic disease; 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 28 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/inducers of CYP3A, strong CYP2D6 inhibitors 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.

 NCT06125522
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 Belgium, Puerto Rico, United States
Conditions

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

 Breast Cancer
Study Website: View Trial Website
Additional Details

C4891024 is a prospective, open-label, multicenter, Phase 1b/2 sub-study to evaluate the safety, antitumor activity, and PK of ARV-471 with samuraciclib 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 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 Samuraciclib

ARV-471 administered orally QD continuously and Samuraciclib administered orally QD continuously on 28-day cycles

Interventions

Drug: - vepdegestrant

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

Drug: - Samuraciclib

Daily oral dosages of Samuraciclib continuously, dose escalation/de-escalation in Phase 1b until RP2D determined, 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.

Highlands Oncology Group, Fayetteville, Arkansas

Status

Not yet recruiting

Address

Highlands Oncology Group

Fayetteville, Arkansas, 72703

Highlands Oncology Group, Rogers, Arkansas

Status

Not yet recruiting

Address

Highlands Oncology Group

Rogers, Arkansas, 72758

Highlands Oncology Group, Springdale, Arkansas

Status

Not yet recruiting

Address

Highlands Oncology Group

Springdale, Arkansas, 72762

UCHealth Poudre Valley Hospital, Fort Collins, Colorado

Status

Recruiting

Address

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, 80524

UCHealth Harmony, Fort Collins, Colorado

Status

Recruiting

Address

UCHealth Harmony

Fort Collins, Colorado, 80528

UCHealth Greeley Hospital, Greeley, Colorado

Status

Recruiting

Address

UCHealth Greeley Hospital

Greeley, Colorado, 80634

UCHealth - Medical Center of the Rockies, Loveland, Colorado

Status

Recruiting

Address

UCHealth - Medical Center of the Rockies

Loveland, Colorado, 80538

Memorial Hospital East, Shiloh, Illinois

Status

Recruiting

Address

Memorial Hospital East

Shiloh, Illinois, 62269

Siteman Cancer Center - Shiloh, Shiloh, Illinois

Status

Recruiting

Address

Siteman Cancer Center - Shiloh

Shiloh, Illinois, 62269

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

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

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

International Sites

Antwerp University Hospital, Edegem, Antwerpen, Belgium

Status

Not yet recruiting

Address

Antwerp University Hospital

Edegem, Antwerpen, 2650

Institut Jules Bordet, Anderlecht, Bruxelles-capitale, Région DE, Belgium

Status

Not yet recruiting

Address

Institut Jules Bordet

Anderlecht, Bruxelles-capitale, Région DE, 1070

BRCR Global - Mayagüez, Mayaguez, Puerto Rico

Status

Not yet recruiting

Address

BRCR Global - Mayagüez

Mayaguez, , 00682

Rio Piedras, Puerto Rico

Status

Not yet recruiting

Address

Pan American Center for Oncology Trials, LLC

Rio Piedras, , 00935

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