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PF-07220060 + PF-07104091 for Breast Cancer

Not currently recruiting at 52 trial locations

Overseen ByPfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Must not be taking: CDK4/6 inhibitors, SERDs, Everolimus, PPIs

Disqualifiers: Active malignancy, CNS metastases, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of two study medicines, PF-07220060 (Atirmociclib) and PF-07104091, for individuals with breast cancer or other solid tumors. It consists of two parts: the first part experiments with different doses, while the second part explores various combinations of the medicines. The goal is to determine the highest safe dose and assess the effectiveness of these medicines in treating breast cancer. Suitable candidates include those with breast cancer who have undergone prior treatments and those with other solid tumors lacking current treatment options. Participants will take the medications orally, undergo x-ray imaging, and be monitored for about two years. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does exclude participants using certain drugs that affect heart rhythm or specific enzymes. It's best to discuss your current medications with the trial team to see if they might be an issue.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the drugs PF-07220060 and PF-07104091 have been tested for safety in patients with advanced or spreading solid tumors. These drugs target specific proteins (CDK4 and CDK2) that aid cancer cell growth. Early results suggest that most patients tolerate the treatment well.

In previous studies, patients experienced some side effects, which is common with cancer treatments. These included nausea, tiredness, and low blood cell counts. However, most side effects were manageable and did not require stopping the treatment.

Since this clinical trial is in its early stages, it primarily focuses on checking safety and determining the right dose. While there is some evidence of safety, more information is needed to understand all possible risks. As with any treatment, discussing personal health concerns with a doctor before joining a trial is important.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07220060 and PF-07104091 for breast cancer because they offer a new approach by combining targeted therapies. Unlike traditional treatments like chemotherapy, which can affect both cancerous and healthy cells, this combination targets specific proteins involved in cancer cell growth. PF-07220060 and PF-07104091 work together to disrupt pathways that breast cancer cells rely on for survival, potentially leading to more effective and less harmful treatment. Additionally, some trial arms explore combining these drugs with fulvestrant or letrozole, which are standard hormone therapies, aiming to enhance their effectiveness against certain types of breast cancer. This innovative strategy could provide new hope for better outcomes in patients who have limited options with existing treatments.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that PF-07220060 and PF-07104091, studied together in this trial, are promising treatments for breast cancer. Early findings suggest that PF-07220060 targets a protein called CDK4, which aids cancer cell growth, while PF-07104091 targets CDK2, another protein involved in cancer cell growth. In this trial, these drugs are combined in various treatment arms to halt cancer progression by interfering with these proteins. Although researchers are still studying these treatments, early results offer hope for their effectiveness in treating breast cancer. As more information becomes available, a clearer understanding of their potential benefits will emerge.¹ ² ³ ⁴ ⁶

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

See 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.

See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of PF-07220060 with PF-07104091 to determine the highest safe dose

28 days per cycle

Multiple visits per cycle

Dose Expansion

Participants receive one of two study medicine combinations to evaluate safety and effectiveness

Approximately 2 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

PF-07104091
PF-07220060

Trial Overview

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.

How Is the Trial Designed?

Treatment 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