What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as hormone therapies (e.g., tamoxifen, aromatase inhibitors), chemotherapy (e.g., paclitaxel, carboplatin), and targeted therapies (e.g., trastuzumab), have a range of side effects. Hormone therapies can cause hot flashes, bone density loss, and cardiovascular risks. Chemotherapy is associated with neurotoxicity, granulocytopenia, anemia, nausea, and fatigue. Targeted therapies like trastuzumab can lead to cardiac dysfunction and infusion-related reactions. The combination therapy of PF-07220060 and PF-07104091 being studied may have similar side effects, including potential gastrointestinal issues, fatigue, and hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several combination therapies and targeted treatments for breast cancer. Notable examples include the combination of trastuzumab (Herceptin) with pertuzumab (Perjeta) and docetaxel for HER2-positive breast cancer, and the combination of palbociclib (Ibrance) with letrozole for HR-positive, HER2-negative advanced or metastatic breast cancer. These treatments, like the combination of PF-07220060 and PF-07104091 being studied, aim to improve efficacy by targeting specific pathways involved in cancer growth and progression.

What other types of research exist?

Promising alternatives to PF-07220060 and PF-07104091 for breast cancer treatment include the combination of fulvestrant plus everolimus, which has shown safety and efficacy in hormone-receptor positive, HER2-negative breast cancer. Additionally, the pan-PI3K inhibitor buparlisib in combination with fulvestrant is another novel option demonstrating activity in clinical trials.

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PF-07220060 + PF-07104091 for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Refractory HR-positive/HER2-positive BC

Prior systemic Treatment Part 1: HR-positive/HER2-negative BC At least 1 line of SOC, including CDK4/6 inhibitor therapy and Endocrine Therapy, for advanced or metastatic disease. Prior chemotherapy in the metastatic setting is allowed.

Must not have

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

Known active uncontrolled or symptomatic central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through disease progression or study completion (approximately 2 years)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones may include nausea, fatigue, allergic reactions to medications involved in the study (PF-07220060 or PF-07104091), as well as potential impacts on liver function which will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have had at least one standard treatment for my HR-positive/HER2-negative breast cancer, including CDK4/6 inhibitors and hormone therapy.

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My breast cancer is HR-positive and HER2-negative.

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I have a solid tumor that is not breast cancer.

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I have a cancer lesion that can be measured, including in the skin or bone.

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I have HR+/HER2+ breast cancer and received at least one HER2 therapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is hormone receptor positive and HER2 negative.

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I have had only one chemotherapy treatment for my advanced cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have active brain metastases that are not under control.

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I stopped taking CDK 4/6 inhibitors due to side effects.

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More than a quarter of my bone marrow has been exposed to radiation.

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I have previously been treated with a CDK4/6 inhibitor for advanced disease.

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I have received treatment for advanced-stage disease before.

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I haven't had any cancer except for certain skin cancers or cervical pre-cancer in the last 3 years.

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I have high blood pressure that needs treatment.

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I have an active inflammatory disease in my digestive system.

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I am allergic to specific cancer medications including PF-07220060, PF-07104091, letrozole, fulvestrant, or goserelin.

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I am currently taking medication that can affect my heart's rhythm.

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I have had intense chemotherapy that needed stem cell support.

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I am not using, nor do I need, drugs that strongly affect certain liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through disease progression or study completion (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through disease progression or study completion (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through disease progression or study completion (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

Number of participants with corrected QT (QTc) interval

Secondary study objectives

Duration of Response (DoR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole

Objective response rate (ORR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole

Progression-Free Survival (PFS) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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