Study on PF-07220060 and Fulvestrant for Advanced or Metastatic HR-positive, HER2-negative Breast Cancer After Previous Treatment

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06105632

Provider View

This clinical trial is testing a new medicine, PF-07220060, combined with fulvestrant, to see if it is safe and effective for people with advanced or metastatic breast cancer that is HR-positive and HER2-negative, after previous treatments have not worked.

Patient Parameters

Program Overview

The study aims to find out if the combination of PF-07220060 and fulvestrant is safe and effective compared to other treatments chosen by the study doctor for people with advanced or metastatic breast cancer. Advanced cancer is difficult to cure, and metastatic cancer has spread to other parts of the body. Participants will either receive PF-07220060 with fulvestrant or the study doctor's choice of treatment, which could be fulvestrant alone or everolimus with exemestane. The study will monitor participants until their cancer worsens, they experience severe side effects, or they choose to stop.

Eligibility Criteria

Inclusion Criteria

  • Have breast cancer that is advanced or has spread and cannot be treated with surgery or radiation to cure it.
  • Have a tumor that is hormone receptor (HR)-positive and HER2-negative.
  • Can provide a sample of the tumor tissue.
  • Have previously received a specific type of treatment (CDK4/6 inhibitor and NSAI) and the cancer progressed during or after this treatment.
  • Have measurable cancer or bone-only disease as defined by specific criteria.
  • Be in good enough health to participate, with a performance status score of 2 or less.

Exclusion Criteria

  • Have any medical or mental health condition that could increase the risk of participating in the study.
  • Be in a critical condition with life-threatening complications.
  • Have uncontrolled or symptomatic cancer spread to the brain or spinal cord.
  • Have previously been treated with everolimus or other experimental cancer drugs.
  • Have had chemotherapy for advanced cancer.
  • Have had radiation therapy within two weeks before starting the study.
  • Need to use certain prohibited foods, supplements, or medications during the study.
  • Have poor kidney or liver function or blood abnormalities.

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