PF-07220060 + PF-07104091 for Breast Cancer

Recruiting at 48 trial locations

Overseen By Pfizer 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

192 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug PF-07220060 + PF-07104091 for breast cancer?

Research shows that similar drugs, like palbociclib, which are also CDK 4/6 inhibitors, have been effective in prolonging progression-free survival in patients with hormone receptor-positive, HER2-negative metastatic breast cancer when combined with endocrine therapy. ^{1 2 3 4 5}

What makes the drug PF-07220060 + PF-07104091 unique for breast cancer treatment?

The drug combination PF-07220060 (Atirmociclib) and PF-07104091 is unique because it involves a novel approach targeting specific proteins involved in cell cycle regulation, potentially offering a new option for patients with breast cancer who may not respond to existing treatments like palbociclib, another CDK4/6 inhibitor. ^{1 3 4 6 7}

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Part 2C Experimental Treatment 1 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 2B Experimental Treatment 1 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 2A Experimental Treatment 1 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 8 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group V: Part 1 Dose Escalation - Dose Level 7 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group VI: Part 1 Dose Escalation - Dose Level 6 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group VII: Part 1 Dose Escalation - Dose Level 5 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group VIII: Part 1 Dose Escalation - Dose Level 4 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group IX: Part 1 Dose Escalation - Dose Level 3 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group X: Part 1 Dose Escalation - Dose Level 2 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Group XI: Part 1 Dose Escalation - Dose Level 1 Experimental Treatment 1 Intervention

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

In a real-world study of 191 women with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer, the combination of palbociclib and endocrine therapy showed a clinical benefit rate of 59.8%, with a median progression-free survival (PFS) of 13 months.

The treatment was more effective when given as a first-line therapy, resulting in a median PFS of 14 months, compared to shorter PFS durations in later treatment lines, indicating that earlier intervention may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study. Palumbo, R., Torrisi, R., Sottotetti, F., et al.[2022]

In the FLIPPER trial, the combination of palbociclib and fulvestrant significantly improved progression-free survival (PFS) in postmenopausal women with HR+/HER2- advanced breast cancer compared to placebo and fulvestrant.

Patient-reported outcomes indicated that while global health status and quality of life (QoL) were maintained during treatment with palbociclib/fulvestrant, the time to deterioration in QoL was longer with placebo/fulvestrant, suggesting that palbociclib/fulvestrant is a beneficial treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial. Tibau, A., Martínez, MT., Ramos, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Genomic Markers of CDK 4/6 Inhibitor Resistance in Hormone Receptor Positive Metastatic Breast Cancer. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exploratory analysis of biomarkers associated with clinical outcomes from the study of palbociclib plus endocrine therapy in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Real-World Alternative Dosing Strategies of Palbociclib on Progression-Free Survival in Patients with Metastatic Breast Cancer. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Optimizing Palbociclib Therapy Across the Age Spectrum: Hypothetical, Illustrative Case Scenarios in HR+, HER2-Metastatic Breast Cancer. [2021]