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Cancer Vaccine
PF-07220060 + Fulvestrant for Advanced Breast Cancer
Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is looking at the safety and effectiveness of a new medicine (PF-07220060) in combination with fulvestrant for people with advanced or metastatic breast cancer. Participants must be
Who is the study for?
This trial is for adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has worsened after prior treatment. Participants must have a tumor responsive to hormones, provide a tissue sample, and have an ECOG Performance Status of ≤2. They should not be candidates for surgery or radiation with curative intent and must have progressed during or after CDK4/6i treatment.
What is being tested?
The study compares the effectiveness of PF-07220060 taken orally twice daily combined with fulvestrant injections versus standard treatments chosen by the doctor (fulvestrant alone or everolimus with exemestane). The goal is to determine if PF-07220060 plus fulvestrant is safe and more effective than other options.
What are the potential side effects?
Potential side effects include reactions at the injection site from fulvestrant shots, digestive issues from oral medications like PF-07220060 and exemestane, as well as possible increased risk of infections due to immune system changes caused by everolimus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment2 Interventions
PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
Group II: Arm BActive Control3 Interventions
Investigator's choice of therapy of either:
* Fulvestrant alone (a solution for injection), or
* Everolimus in combination with exemestane, both a tablet to be taken by mouth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3790
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,716,682 Total Patients Enrolled
115 Trials studying Breast Cancer
41,383 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,538 Total Patients Enrolled
47 Trials studying Breast Cancer
17,788 Patients Enrolled for Breast Cancer