Study on the Safety and Effects of PF-07220060 and PF-07104091 in People with Breast Cancer and Other Solid Tumors

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05262400

Provider View

This clinical trial is exploring the safety and effects of two study medicines, PF-07220060 and PF-07104091, in people with breast cancer and other solid tumors. The study is divided into two parts, with participants receiving the medicines by mouth over about two years.

Patient Parameters

Program Overview

The purpose of this study is to understand how safe and effective the study medicines PF-07220060 and PF-07104091 are for people with breast cancer and other solid tumors. The study has two parts. In Part 1, we are looking for participants with breast cancer, including HR-positive/HER2-negative and refractory HR-positive/HER2-positive types, as well as those with other solid tumors. In Part 2, we are seeking participants with HR-positive/HER2-negative breast cancer. Part 1 will involve gradually increasing doses of the study medicines to find the safest amount. In Part 2, participants will receive one of two combinations of the study medicines. All participants will take the medicines by mouth and will be monitored for safety and effectiveness over about two years, including receiving x-ray imaging.

Eligibility Criteria

Exclusion Criteria

  • Permanent discontinuation of previous CDK 4 or CDK2 inhibitor treatment due to side effects.
  • Previous treatment with CDK 4/6 inhibitors, SERDs, everolimus, or PI3K-mTOR pathway inhibitors for advanced disease in certain study parts.
  • Previous treatment with investigational endocrine therapy for advanced disease in certain study parts.
  • Recurrence of disease within 12 months of completing treatment with specific aromatase inhibitors.
  • Any prior systemic treatment for advanced disease in certain study parts.
  • Previous radiation to more than 25% of the bone marrow.
  • Current use of drugs that may affect heart rhythm (QTc prolongation).
  • Current or expected use of certain strong enzyme inhibitors or inducers.
  • Participation in other drug studies within 4 weeks before joining this study.
  • Any other active cancer within 3 years before joining, except for certain skin cancers or cervical carcinoma in situ.
  • Major surgery within 4 weeks before joining.
  • Radiation therapy within 4 weeks before joining.
  • Significant high blood pressure.
  • Known allergies to study medicines or related drugs.
  • Known blood clotting issues, except for certain allowed anticoagulants.
  • Uncontrolled or symptomatic brain metastases.
  • Active inflammatory bowel disease.
  • Current or expected use of Proton Pump Inhibitors within 14 days before starting the study.
  • Previous high-dose chemotherapy needing stem cell rescue.
  • Active, uncontrolled infections, including hepatitis B, hepatitis C, or HIV/AIDS.
  • Other specific exclusion criteria may apply.

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