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Vepdegestrant + Samuraciclib for Advanced Breast Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG PS ≤1
Histological or cytological diagnosis of breast cancer not amenable to surgical resection with curative intent
Must not have
Known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions
Known active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to approximately 3 year
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the safety & effects of vepdegestrant when given with other medicines for advanced metastatic breast cancer. Participants take vepdegestrant & samuraciclib pills daily & have visits every 4 weeks.
Who is the study for?
This trial is for individuals with advanced or metastatic breast cancer that's hormone-sensitive and not responding to prior treatments. Participants can have had up to two previous therapies for advanced disease, including one CDK4/6 inhibitor regimen, and must have at least one measurable lesion. They should be in a relatively stable condition (ECOG PS ≤1) without life-threatening visceral crises, significant lung function issues, recent other cancers except certain skin/cervix ones, inflammatory breast cancer, serious heart diseases or conditions affecting the kidneys, liver or bone marrow.
What is being tested?
The study tests vepdegestrant combined with samuraciclib taken orally once daily at home by patients with tough-to-treat breast cancer. The goal is to determine the safety and effectiveness of this combination therapy in controlling cancer that has spread beyond the breast.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions from oral cancer medications such as nausea, fatigue, risk of infection due to lowered immunity; specific concerns could also arise from drug interactions leading to heart rhythm problems (QT interval prolongation) or lung issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My breast cancer cannot be removed with surgery to cure it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had lung problems caused by medication before.
Select...
I currently have an active infection.
Select...
I have recently been diagnosed with brain metastases or related conditions.
Select...
I have heart problems or significant heart disease.
Select...
I have inflammatory breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to approximately 3 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 3 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Drug Drug Interaction: To evaluate the effect of samuraciclib on PK of ARV 471.
Drug Drug Interaction: • To evaluate the effect of ARV 471 on PK of samuraciclib.
Phase 1b: Number of Participants With Dose Limiting Toxicities
+1 moreSecondary study objectives
Phase 1b and Phase 2: Duration of Response by investigator assessment.
Phase 1b and Phase 2: Plasma concentrations of ARV-471 and samuraciclib.
Phase 1b and Phase 2: Progression Free Survival by investigator assessment.
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ARV-471 in combination with SamuraciclibExperimental Treatment2 Interventions
ARV-471 administered orally QD continuously and Samuraciclib administered orally QD continuously on 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vepdegestrant
2024
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,114 Total Patients Enrolled
114 Trials studying Breast Cancer
41,316 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
18 Previous Clinical Trials
2,380 Total Patients Enrolled
7 Trials studying Breast Cancer
1,587 Patients Enrolled for Breast Cancer
Carrick Therapeutics LimitedIndustry Sponsor
4 Previous Clinical Trials
283 Total Patients Enrolled
2 Trials studying Breast Cancer
109 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,970 Total Patients Enrolled
46 Trials studying Breast Cancer
17,721 Patients Enrolled for Breast Cancer