Study on PF-07248144 and Fulvestrant for HR-positive, HER2-negative Advanced or Metastatic Breast Cancer After Previous Treatment
Sponsor: Pfizer
ClinicalTrials ID:NCT07062965
This clinical trial is exploring the safety and effects of a new medicine, PF-07248144, when used with fulvestrant to treat advanced or metastatic breast cancer that is HR-positive and HER2-negative, in patients whose cancer has worsened after previous treatment.
Patient Parameters
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Program Overview
The study aims to find out if the combination of PF-07248144 and fulvestrant is safe and effective for treating advanced or metastatic breast cancer that is HR-positive and HER2-negative. HR-positive breast cancer grows with the help of hormones like estrogen. HER2-negative cancer cells have little or no HER2 protein, which usually helps cells grow. This type of cancer may grow more slowly and is less likely to spread. The study is for patients whose cancer has progressed after treatment with CDK 4/6 inhibitors. Participants will either receive PF-07248144 with fulvestrant or continue their usual treatment with everolimus and hormone therapy. The study will compare the two groups to see if the new combination works better.
Description
Participants in this study will be divided into two groups. One group will receive the new treatment, PF-07248144, along with fulvestrant. PF-07248144 is a tablet taken daily at home, while fulvestrant is given as two injections at the clinic. The other group will continue with their usual treatment, which includes everolimus and either exemestane or fulvestrant, both taken as tablets at home. The study will compare the experiences of both groups to determine if the new treatment is safe and effective.
Eligibility Criteria
Inclusion Criteria
- Have HR-positive, HER2-negative breast cancer that is advanced or has spread and cannot be treated with surgery or radiation to cure it.
- Have previously received CDK4/6 inhibitor therapy with hormone therapy for advanced or metastatic cancer, and the cancer worsened during or within 12 months after the last treatment.
- May have received CDK4/6 inhibitors or hormone therapy alone or together for advanced cancer, and may have had treatments targeting specific genes like ESR1 or BRCA1/2.
- Have cancer that can be measured by scans or tests, or have bone-only disease that cannot be measured.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have specific genetic changes in the cancer, such as PIK3CA, AKT1, or PTEN alterations.
- Have had more than two previous treatments for advanced or metastatic cancer.
- Have received chemotherapy for advanced cancer, except if it was given before the cancer spread.
- Have medical or mental health conditions that could increase the risk of participating in the study or make participation inappropriate.
- Have kidney, liver, or blood problems.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group, PA | 72703 | Fayetteville | Arkansas |
| Highlands Oncology Group, PA | 72758 | Rogers | Arkansas |
| Highlands Oncology Group, PA | 72762 | Springdale | Arkansas |
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