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

NCT05732428 | Completed Phase 1

• 2 other identifiers: C4891018NCT05732428
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Single dose Cmax (Maximum plasma concentration)

  Maximum plasma concentration

  0, 1, 2, 4, 6, 8, 12, 24 hours post-dose up to Day 2

• Single dose AUCtau

  Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 24 hours (QD dosing)

  0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2

• Multiple dose Cmax

  Maximum Observed Plasma Concentration (Cmax)

  0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71

• Multiple dose AUCtau

  Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.

  0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71

Secondary Outcomes (26)

• Objective Response Rate - Percentage of Participants With Objective Response

  Baseline up to 24 weeks

• Percentage of Participants With Clinical Benefit

  Baseline up to 24 weeks

• Duration of Objective Response (DOR)

  From the date of first documented response (CR or PR) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks

• Presence (rate) or absence of blood biomarkers

  immediately after the end of treatment

• Number of Participants With Notable Electrocardiogram (ECG) Values

  From baseline up to 28 days after last dose of study drug

Study Arms (1)

ARV-471

EXPERIMENTAL

Drug: ARV-471

Interventions

ARV-471 DRUG

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

ARV-471

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Arvinas Estrogen Receptor, Inc.: collaborator

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Jilin Province Tumor Hospital

Changchun, Jilin, 130000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 17, 2023
• Study Start: February 20, 2023
• Primary Completion: March 29, 2024
• Study Completion: November 1, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)