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Cancer Vaccine

Arm A for 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 from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary outcome measures

Ctrough of PF-07220060

Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1

EORTC QLQ

+12 more

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

~3690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,472 Total Patients Enrolled

112 Trials studying Breast Cancer

36,444 Patients Enrolled for Breast Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,690 Total Patients Enrolled

43 Trials studying Breast Cancer

12,808 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study actively seeking participants at the moment?

"As per clinicaltrials.gov, this investigation is actively enrolling volunteers. It was initially listed on 1/9/2024 and most recently revised on 2/29/2024."

Answered by AI

What is the level of safety associated with Arm A in regards to individuals?

"Our team at Power has rated the safety of Arm A as 3 on a scale from 1 to 3, given that this trial is in Phase III and has gathered evidence supporting both effectiveness and safety through numerous iterations."

Answered by AI

At how many distinct locations is this clinical trial currently being conducted?

"Currently, this clinical study is enlisting participants from 21 diverse sites. These include centers in La Rioja, Taipei, and Washington among various other locations. Opting for the closest site can reduce travel burdens when you decide to participate."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"A total of 510 eligible participants are required to conduct this clinical trial successfully. Pfizer, the study sponsor, will oversee operations at multiple sites such as Fundación CORI para la Investigación y Prevención del Cáncer in La Rioja, District of Columbia and Koo Foundation Sun Yat-Sen Cancer Center in Taipei, Illinois."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

2024. "A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105632.

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