PF-07248144 plus fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer after prior treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial testing the combination of the investigational agent PF-07248144 with fulvestrant in people with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer. Eligible participants have measurable disease or bone-only disease, ECOG performance status 0–1, and progression after prior lines of therapy including CDK4/6 inhibitors. The trial will collect safety and effect data to determine whether the combination improves outcomes compared with existing options. Patients with documented PIK3CA, AKT1, or PTEN alterations are excluded, and the trial is conducted at Ironwood Cancer & Research Centers in the Phoenix, Arizona area.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
* Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
* Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

Exclusion Criteria:

* Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
* Received greater than two prior lines of systemic therapy in the advance or metastatic setting
* Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
* Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
* Renal impairment, hepatic dysfunction, or hematologic abnormalities.

Where it's running

• Alaska Oncology and Hematology, LLC
  Anchorage, Alaska, United States Recruiting
• Ironwood Cancer & Research Centers
  Chandler, Arizona, United States Recruiting
• Banner Gateway Medical Center
  Gilbert, Arizona, United States Recruiting
• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Gilbert, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Glendale, Arizona, United States Recruiting

+383 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.