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A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorPfizer
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 23, 2026 → Feb 26, 2027
See other at-risk trials from Pfizer

Record History

  1. Primary and study completion pushed from Aug 23, 2026 to Feb 26, 2027 Enrollment increased: 192 → 235 participants · Trial sites reduced: 51 → 44 locationsv34 Show all 3 changesShow less
    • Enrollment increased: 192 → 235 participants
    • Trial sites reduced: 51 → 44 locations
  2. 4 versions Re-verified since Oct 1, 2024, no change to tracked fieldsv30-v33
  3. Enrollment target: 190 to 192v29
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 240 to confirmed 190 · Primary and study completion dates: Dec 29, 2026 to Aug 23, 2026 · Site details revised at 51 of 51 sitesv28 Show all 4 changesShow less
    • Enrollment target: estimated 240 to confirmed 190
    • Primary and study completion dates: Dec 29, 2026 to Aug 23, 2026
    • Site details revised at 51 of 51 sites
  5. Re-verified, no change to tracked fieldsv27
Show 25 earlier versionsHide 25 earlier versions
  1. Site details revised at 1 of 51 sitesv26
  2. Study sites: 50 to 51v25
  3. Study sites: 49 to 50 Primary and study completion dates: Sep 13, 2026 to Dec 29, 2026v24 Show all 2 changesShow less
    • Primary and study completion dates: Sep 13, 2026 to Dec 29, 2026
  4. Study sites: 45 to 49 Completion date: Nov 28, 2026 to Sep 13, 2026v23 Show all 2 changesShow less
    • Completion date: Nov 28, 2026 to Sep 13, 2026
  5. Study sites: 42 to 45 Primary completion date: Jun 30, 2026 to Sep 13, 2026 · Completion date: Sep 21, 2026 to Nov 28, 2026v22 Show all 3 changesShow less
    • Primary completion date: Jun 30, 2026 to Sep 13, 2026
    • Completion date: Sep 21, 2026 to Nov 28, 2026
  6. Phase: Phase 2 to Phase 1/2 Enrollment target: 144 to 240 · Study sites: 40 to 42 · Completion date: Sep 13, 2026 to Sep 21, 2026v21 Show all 4 changesShow less
    • Enrollment target: 144 to 240
    • Study sites: 40 to 42
    • Completion date: Sep 13, 2026 to Sep 21, 2026
  7. Phase: Phase 1/2 to Phase 2 Study sites: 39 to 40v20 Show all 2 changesShow less
    • Study sites: 39 to 40
  8. Site details revised at 1 of 39 sitesv19
  9. Study sites: 30 to 39v18
  10. Phase: Phase 2 to Phase 1/2 Primary completion date: Jul 23, 2026 to Jun 30, 2026 · Completion date: Jul 23, 2027 to Sep 13, 2026 · Site details revised at 1 of 30 sitesv17 Show all 4 changesShow less
    • Primary completion date: Jul 23, 2026 to Jun 30, 2026
    • Completion date: Jul 23, 2027 to Sep 13, 2026
    • Site details revised at 1 of 30 sites
  11. Phase: Phase 1/2 to Phase 2 Study sites: 29 to 30v16 Show all 2 changesShow less
    • Study sites: 29 to 30
  12. Site details revised at 2 of 29 sitesv15
  13. Study sites: 28 to 29v14
  14. Study sites: 22 to 28v13
  15. Study sites: 20 to 22v12
  16. Study sites: 18 to 20 Primary completion date: Dec 30, 2026 to Jul 23, 2026 · Completion date: Dec 30, 2027 to Jul 23, 2027v11 Show all 3 changesShow less
    • Primary completion date: Dec 30, 2026 to Jul 23, 2026
    • Completion date: Dec 30, 2027 to Jul 23, 2027
  17. Phase: Phase 2 to Phase 1/2 Study sites: 6 to 18 · Primary completion date: Jan 30, 2027 to Dec 30, 2026 · Completion date: Jan 30, 2028 to Dec 30, 2027 · 3 morev10 Show all 7 changesShow less
    • Study sites: 6 to 18
    • Primary completion date: Jan 30, 2027 to Dec 30, 2026
    • Completion date: Jan 30, 2028 to Dec 30, 2027
    • Interventions: PF-07104091 + PF-07220060 + fulvestrant dose expansion (Drug), PF-07104091 + PF-07220060 + fulvestrant dose expansion (Drug), PF-07104091 +… to PF-07104091 + PF-07220060 + fulvestrant dose expansion (Drug), PF-07104091 + PF-07220060 + fulvestrant dose expansion (Drug), PF-07104091 +…
    • Eligibility criteria expanded, about 56 words
    • Study arms: 8 to 11

    See this version in full on ClinicalTrials.gov ↗

  18. Site details revised at 2 of 6 sitesv9
  19. Study title shortened, about 20 wordsv8 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  20. Phase: Phase 1/2 to Phase 2 Primary completion date: Oct 12, 2026 to Jan 30, 2027 · Completion date: Oct 12, 2027 to Jan 30, 2028 · Site details revised at 1 of 6 sitesv7 Show all 4 changesShow less
    • Primary completion date: Oct 12, 2026 to Jan 30, 2027
    • Completion date: Oct 12, 2027 to Jan 30, 2028
    • Site details revised at 1 of 6 sites
  21. Phase: Phase 2 to Phase 1/2 Study sites: 3 to 6v6 Show all 2 changesShow less
    • Study sites: 3 to 6
  22. Study sites: 2 to 3v5
  23. Primary completion date: Dec 30, 2026 to Oct 12, 2026 Completion date: Dec 30, 2027 to Oct 12, 2027 · Site details revised at 1 of 2 sitesv4 Show all 3 changesShow less
    • Completion date: Dec 30, 2027 to Oct 12, 2027
    • Site details revised at 1 of 2 sites
  24. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Mar 17, 2022 to Mar 14, 2022v3 Show all 3 changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 17, 2022 to Mar 14, 2022
  25. Phase: Phase 1/2 to Phase 2 Study sites: 0 to 1 · Primary completion date: Nov 3, 2026 to Dec 30, 2026 · Completion date: Nov 3, 2027 to Dec 30, 2027v2 Show all 4 changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Nov 3, 2026 to Dec 30, 2026
    • Completion date: Nov 3, 2027 to Dec 30, 2027
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
433 trials monitored
See 31 trials at risk
Breast Cancer
5,213 trials monitored
See 275 trials at risk
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2). In part 1, we are seeking participants who: * Have been diagnosed with Breast Cancer (BC) of either types: * Have HR+, HER2- BC * Refractory HR-positive/HER2-positive BC * Have other solid tumors other than BC In part 2, we are seeking participants who: -Have HR-positive/HER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091. In part 2, participants will take 1 of 2 study medicine combinations. This will help us decide the highest amount of study medicines that can be safety given to people. All participants in this study will receive PF-07220060 with PF-07104091 by mouth. We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective. Participants will take part in this study for about 2 years. During this time, they will receive the study medicine, an x-ray imaging, and will be observed for safety and effects of the study medicines.
Trial Details
NCT Number NCT05262400
Lead Sponsor Pfizer
Conditions Breast Cancer, Solid Tumors
Enrollment 235 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov