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

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a combination of two drugs, PF-07220060 and PF-07104091, in people with breast cancer or other solid tumors. The goal is to find the highest dose of the combination that is still safe and well-tolerated, and to see if the combination is safe and tolerable when combined with endocrine therapy.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Incidence of participants with clinical laboratory abnormalities

Number of participants with corrected QT (QTc) interval

+2 more

Secondary outcome measures

Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07220060 and PF-07104091 together

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

Maximum plasma concentration (Cmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose

+5 more

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