A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
Sponsor: Pfizer
ClinicalTrials ID:NCT05262400
This clinical trial evaluates the safety and effects of PF-07220060 and PF-07104091 in participants with HR+, HER2- breast cancer and other solid tumors. Part 1 involves dose escalation, while Part 2 explores combinations with fulvestrant or letrozole. Participants will receive oral administration of the drugs and undergo safety monitoring over approximately two years.
Patient Parameters
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Program Overview
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 Criteria
Exclusion Criteria
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All Study Parts: Permanent treatment discontinuation from prior CDK 4 and/or CDK2 inhibitor due to treatment related toxicity.
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Part 2B and 1C: Prior treatment with any CDK 4/6 inhibitor, or SERDs (e.g. fulvestrant), or everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway for advanced disease.
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Parts 2B and 2C: Prior treatment with any CDK4/6 inhibitor for advanced disease.
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Parts 2B and 2C: Prior treatment with an investigational endocrine therapy for advanced disease.
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Part 2C: Prior neoadjuvant or adjuvant treatment with a nonsteroidal aromatase inhibitor AI (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.
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Part 2C: Any prior systemic treatment for advanced disease.
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Prior irradiation to >25% of the bone marrow
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Current use of drugs which have a risk for QTc prolongation
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Current use or anticipated need for food or drugs that are known strong CYP3A4/5, strong UGT2B7 or UGT1A9 inhibitors or inducers
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Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Participants with any other active malignancy within 3 years prior to enrollment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, Bowen's disease
- Major surgery within 4 weeks prior to study entry
- Radiation therapy within 4 weeks prior to study entry.
- Clinically important hypertension
- Known or suspected hypersensitivity to PF-07220060, PF-07104091, letrozole, fulvestrant, or goserelin (or equivalent to induce chemical menopause if applicable)
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Known abnormalities in coagulation. Anticoagulation with subcutaneous heparin or prophylactic doses of anticoagulant are allowed
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Known active uncontrolled or symptomatic central nervous system (CNS) metastases
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Active inflammatory GI disease
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Current use or anticipated need for Proton Pump Inhibitors (PPI) within 14 days prior to first dose of the study intervention
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Previous high-dose chemotherapy requiring stem cell rescue
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Participants with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
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Other protocol specific exclusion criteria may apply
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Administrative Address: UCLA Hematology/Oncology | 90095 | Los Angeles | California |
| Ronald Reagan UCLA Medical Center | 90095 | Los Angeles | California |
| UCLA Hematology/Oncology | 90095 | Los Angeles | California |
| UCLA Hematology / Oncology-Parkside | 90404 | Santa Monica | California |
| UCLA Hematology/Oncology-Santa Monica | 90404 | Santa Monica | California |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| START Midwest | 49546 | Grand Rapids | Michigan |
| Saint Luke's Cancer Institute | 64111 | Kansas City | Missouri |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | 75246 | Dallas | Texas |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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