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

Condition(s) studied

Investigational drug(s) / intervention(s)

vepdegestrant: Daily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

PF-07220060: Daily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Participants With Dose-Limiting Toxicities (DLTs): Phase 1b — Cycle 1 (28 days)
  Hematological DLT: neutropenic fever; Grade\>=3 thrombocytopenia associated with Grade\>=2(clinically significant)bleeding and Grade4 neutropenia/thrombocytopenia lasting \<7 days. Non-hematological: Grade\>=3 toxicities clinically significant,except those that were not been maximally treated;Grade 2 aspartate aminotransferase(AST), alanine aminotransferase(ALT)/alkaline phosphatase(ALP) levels at baseline as result of liver/bone metastasis,AST,ALT and ALP level\>8\*baseline/AST/ALT \>5\*baseline for\>=14 days; Hy's Law(concomitant ALT/AST elevation of \>=3\*upper limit of normal \[ULN\], total bilirubin elevation\>=2\*ULN without clear alternative etiology); Grade≥3 electrolyte abnormality with clinical sequelae; QTcF prolongation:any Grade\>=3 QT prolongation without clear alternative etiology;any adverse event (AE) attributed to Vepdegestrant and/or PF-07220060 resulting in failure to deliver 75% of doses for either/both agents and any death not clearly due to underlying disease/extraneous causes.
• Percentage of Participants With Confirmed Objective Response (OR) by Derived Investigator Assessment: Phase 2 — From the date of first dose of study treatment combination until the first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum treatment exposure of 9.5 months for Phase 2)
  OR was defined as best overall response (BOR) of confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as complete disappearance of all target lesions, except for nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes, both target and non-target, must decrease to normal (short axis \<10 millimeter \[mm\]). PR was defined as at least a \>=30% decrease from baseline in the sum of diameters of all target lesions. The short diameter was used in the sum for nodal target lesions, while the longest diameter was used in the sum for non-nodal target lesions, all target lesions were assessed.

Trial sites (58)

+ 18 more sites — see the full list on the official registry below.

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