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Spots Global Cancer Trial Database for 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)

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Trial Identification

Brief Title: 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)

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 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)

Study ID: NCT06125522

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Highlands Oncology Group, Fayetteville, Arkansas, United States

Highlands Oncology Group, Rogers, Arkansas, United States

Highlands Oncology Group, Springdale, Arkansas, United States

UCHealth Poudre Valley Hospital, Fort Collins, Colorado, United States

UCHealth Harmony, Fort Collins, Colorado, United States

UCHealth Greeley Hospital, Greeley, Colorado, United States

UCHealth - Medical Center of the Rockies, Loveland, Colorado, United States

Memorial Hospital East, Shiloh, Illinois, United States

Siteman Cancer Center - Shiloh, Shiloh, Illinois, United States

Siteman Cancer Center - West County, Creve Coeur, Missouri, United States

Siteman Cancer Center - North County, Florissant, Missouri, United States

Barnes-Jewish Hospital, Saint Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Siteman Cancer Center - South County, Saint Louis, Missouri, United States

Siteman Cancer Center - St Peters, Saint Peters, Missouri, United States

Antwerp University Hospital, Edegem, Antwerpen, Belgium

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

BRCR Global - Mayagüez, Mayaguez, , Puerto Rico

Pan American Center for Oncology Trials, LLC, Rio Piedras, , Puerto Rico

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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