A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.

StatusActive, Not Recruiting

PhasePhase 1/2

SponsorPfizer

Started2024-02-19

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary endpoint reworded 2 of 2 changed

See other at-risk trials from Pfizer

Amendment history

2026-10-01

Primary endpoint(s) modified2 entries, revised

Was~~Phase 1b:~~ Number of Participants With Dose Limiting Toxicities, Phase 2: Percentage of Participants With Objective Response by ~~investigator~~ ~~assessment~~

NowNumber of Participants With Dose-Limiting Toxicities (DLTs): Phase 1b, Percentage of Participants With Confirmed Objective Response (OR) by Derived Investigator Assessment: Phase 2

Completion pushed: 2026-09-07 → 2027-05-25

Results posted: 2026-09-30

2026-02-25

Study Status, Contacts/Locations v13

Completion date2026-03-06→2026-09-07

Study sites54→58

2025-09-18

Study Status, Contacts/Locations v12

Study sites54 entries, revised

Showa Medical University Hospital

2025-07-02

Study Status, Study Design, Contacts/Locations v11

Enrollment target65→71

Study sites54 entries, revised

~~South~~START ~~Texas~~San ~~Accelerated Research Therapeutics (START)~~Antonio

2025-04-28

Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v10

Trial statusRecruiting→Active, Not Recruiting

Primary completion date2025-08-14→2025-09-05

Completion date2026-02-13→2026-03-06

Study sites57→54

Show 9 earlier versions

2024-11-01

Study Status, Contacts/Locations v9

Study sites54→57

2024-10-05

Study Status, Contacts/Locations v8

Study sites34→54

2024-08-22

Study Identification, Study Status, Contacts/Locations v7

Study sites11→34

2024-07-15

Study Status v6

Re-verified, no change to tracked fields

2024-05-01

Study Status, Contacts/Locations v5

Study sites10→11

2024-04-04

Study Status, Contacts/Locations v4

Study sites9→10

2024-03-12

Study Identification, Study Status, Contacts/Locations v3

Study sites8→9

2024-03-01

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2

Trial statusNot Yet Recruiting→Recruiting

Primary completion date2026-05-18→2025-08-14

Completion date2026-11-17→2026-02-13

Start dateestimated 2024-02-29→confirmed 2024-02-19

Study sites5→8

2024-02-06

Study Status, Outcome Measures, Contacts/Locations v1

Start date2024-01-08→2024-02-29

Study sites0→5

Secondary endpointsdetails revised at 2 of 17 entries

2024-01-04

Original filing

Pfizer

431 trials monitored

See 32 trials at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: * is hard to treat (advanced) and may have spread to other organs (metastatic). * is sensitive to hormonal therapy (it is called estrogen receptor positive). * is no longer responding to treatments taken before starting this study. All the participants will receive vepdegestrant and PF-07220060. Both medicines will be taken by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicines are safe and effective. Participants will continue to take vepdegestrant and PF-07220060 until: * their cancer is no longer responding, or * side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Trial Details

NCT Number	NCT06206837
Lead Sponsor	Pfizer Collaborators: Arvinas Estrogen Receptor, Inc.
Conditions	Breast Cancer
Enrollment	71 participants
Start Date	2024-02-19
Primary Completion	2025-09-05 (estimated)
Study Completion	2027-05-25 (estimated)
Updated on ClinicalTrials.gov	2026-09-30