A Study to Learn About the Study Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Advanced Breast Cancer in China

Trial Title: A Study to Learn About the Study Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Advanced Breast Cancer in China

NCT ID: NCT05732428

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ARV-471
Description: ARV-471 will be administered orally once daily with food (eg, a light meal of approximately 400 to 600 calories which includes a mixture of fat carbohydrates, and protein) at RP3D for monotherapy defined in study ARV-471-mBC-101, in continuous dosing over 28-day cycles
Arm group label: ARV-471

Summary: The purpose of this clinical trial is to learn about the pharmacokinetics. safety and tolerability of the study medicine (called ARV-471) for the potential treatment of advanced estrogen receptor postive and human epidermal growth factor receptor 2 negative breast cancer. This study is seeking participants have - ER+/HER2- advanced breast cancer - received at least 1 line of endocrine therapy with or without CDK4/6 inhibitor - received up to 2 prior regimens of chemotherapy for advanced setting. All participants in this study will receive ARV-471. ARV-471 will be given by mouth at home once 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 take part in this study until their cancer is no longer responding. During this time, they will have visits at the study clinic about every 4 weeks.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histological or cytological diagnosis of breast cancer with evidence of ER+/HER2- locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. - Received at least 1 line of SOC of endocrine therapy with or without CDK4/6 inhibitor for locally advanced or metastatic disease. - Up to 2 prior regimens of chemotherapy for advanced or metastatic disease setting are allowed. Exclusion Criteria: - Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and clinically stable (including patients with residual CNS symptoms/deficits) off enzyme-inducing anticonvulsants and steroids for at least 28 days prior to first dose of study drug. - Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, serious conduction system abnormalities (eg, bifascicular block defined as right bundle branch and left anterior or posterior hemiblock, 3rd degree AV block), clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital Chinese Academy of Medical Science

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Jilin Province Tumor Hospital

Address:
City: Changchun
Zip: 130000
Country: China

Facility:
Name: The First Affiliated Hospital of Xi'an Jiaotong University

Address:
City: Xi'an
Zip: 710061
Country: China

Facility:
Name: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences

Address:
City: Shanghai
Country: China

Start date: February 20, 2023

Completion date: November 7, 2024

Lead sponsor:
Agency: Pfizer
Agency class: Industry

Collaborator:
Agency: Arvinas Estrogen Receptor, Inc.
Agency class: Industry

Source: Pfizer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05732428
https://pmiform.com/clinical-trial-info-request?StudyID=C4891018