A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07104091 + PF-07220060 + fulvestrant dose expansion: PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
PF-07104091 + PF-07220060 + fulvestrant dose expansion: PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
PF-07104091 + PF-07220060 + letrozole dose expansion: PF-07104091 and PF-07220060 will be administered orally in combination with letrozole
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally
Study summary
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.
Eligibility
Primary outcome measure(s)
- Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle — Cycle 1 (28 days)
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level - Number of participants with treatment emergent adverse events (AEs) — From baseline until end of study treatment or study completion (approximately 2 years)
- Incidence of participants with clinical laboratory abnormalities — From baseline until end of study treatment or study completion (approximately 2 years)
- Number of participants with vital signs abnormalities — From baseline until end of study treatment or study completion (approximately 2 years)
- Number of participants with corrected QT (QTc) interval — From baseline until end of study treatment or study completion (approximately 2 years)
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| Administrative Address: UCLA Hematology/Oncology | Los Angeles | California | |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | |
| UCLA Hematology/Oncology | Los Angeles | California | |
| UCLA Hematology / Oncology-Parkside | Santa Monica | California | |
| UCLA Hematology/Oncology-Santa Monica | Santa Monica | California | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| START Midwest | Grand Rapids | Michigan | |
| Saint Luke's Cancer Institute | Kansas City | Missouri | |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Swedish Medical Center | Seattle | Washington | |
| Swedish Medical Center | Seattle | Washington | |
| Clinica Viedma S. A | Viedma | Río Negro Province | |
| Centro Oncologico Korben | Buenos Aires | Argentina | |
| Clínica Universitaria Reina Fabiola | Córdoba | Argentina | |
| Fundación CORI para la Investigación y Prevención del Cáncer | La Rioja | Argentina | |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia | Ijuí | Rio Grande do Sul | |
| Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa | Porto Alegre | Rio Grande do Sul | |
| Centro de Pesquisa Clínica - Área Administrativa | Porto Alegre | Rio Grande do Sul | |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | |
| Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda | São Paulo | Brazil | |
| Multiprofile Hospital for Active Treatment Serdikamed EOOD | Sofia | Sofia (stolitsa) | |
| Specialized Hospital for Active Treatment of Oncology - Haskovo | Haskovo | Bulgaria | |
| Complex Oncology Center - Plovdiv EOOD | Plovdiv | Bulgaria | |
| Complex Oncology Center - Vratsa | Vratsa | Bulgaria | |
| The First Hospital of Jilin University | Changchun | Jilin | |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | |
| West China Hospital, Sichuan University | Chengdu | Sichuan | |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Fakultni nemocnice Olomouc | Olomouc | Olomouc Region | |
| Fakultni nemocnice Bulovka | Prague | Praha 8 | |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | |
| Všeobecná fakultní nemocnice v Praze | Prague | Czechia | |
| Instituto Nacional de Cancerologia | Mexico City | Mexico City | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | |
| Mérida Investigación Clínica | Mérida | Yucatán | |
| FARMOVS | Bloemfontein | Free State | |
| Wits Clinical Research | Johannesburg | Gauteng | |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [barcelona] |
+ 4 more sites — see the full list on the official registry below.
More Pfizer trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05262400 on ClinicalTrials.gov ↗ ← All trials in the USA