PF-07220060 + PF-07104091 for Breast Cancer

Recruiting in Palo Alto (17 mi)

+48 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests two new oral medicines, PF-07220060 and PF-07104091, in people with different types of breast cancer. It aims to find the safest and most effective dose by gradually increasing the amount given to participants. The study will last several years, during which participants will be monitored for safety and treatment effects.

Eligibility Criteria

This trial is for people with certain types of breast cancer (HR+, HER2- or refractory HR+/HER2+) and those with solid tumors without standard treatment options. Participants must have tried at least one prior therapy, have a measurable lesion, and be in good physical condition (ECOG 0 or 1). They should not have received some specific treatments for advanced disease and must not need certain drugs that affect the study medication.

Inclusion Criteria

My breast cancer is resistant to hormone therapy and is HER2 positive.

I have had hormone therapy for my advanced cancer and it has progressed.

My kidney, liver, and bone marrow are functioning well.

+12 more

Exclusion Criteria

Other protocol specific exclusion criteria may apply

I do not have any active, uncontrolled infections or illnesses related to HIV/AIDS, HBV, or HCV.

I have blood clotting issues but am on low-dose blood thinners.

+19 more

Participant Groups

The trial tests PF-07220060 combined with PF-07104091, taken orally, to determine safety and effectiveness against breast cancer. It has two parts: dose escalation to find the highest safe doses, followed by dose expansion where participants receive set combinations. The goal is to compare experiences across different dosages over approximately two years.

11Treatment groups

Experimental Treatment

Group I: Part 2CExperimental Treatment1 Intervention

PF-07220060 + PF-07104091 + Letrozole (ER+/HER2- Breast Cancer with no prior treatment with any CDK4/6 inhibitor for advanced disease)

Group II: Part 2BExperimental Treatment1 Intervention

PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior endocrine therapy and up to 1 prior line of chemotherapy for advanced or metastatic disease and no prior treatment with any CDK4/6 inhibitor for advanced disease)

Group III: Part 2AExperimental Treatment1 Intervention

PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and Endocrine Therapy)

Group IV: Part 1 Dose Escalation - Dose Level 8Experimental Treatment1 Intervention