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A Study of PF-07248144 with Fulvestrant for HR-positive, HER2-negative Advanced Breast Cancer

This study is looking into a new treatment for advanced or metastatic breast cancer that is HR-positive (meaning hormone receptor positive, where hormones can fuel cancer growth) and HER2-negative (meaning it has little to no HER2 protein, which helps control cell growth). We are testing the safety and effects of a study medicine called PF-07248144 when given together with fulvestrant. You may be able to join if you are 18 or older, have this type of breast cancer, and your cancer has progressed after a previous treatment that included a CDK4/6 inhibitor. The main goal is to see how long people live without their cancer growing or spreading. This study plans to enroll about 400 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is planned to enroll 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until disease progression or death, for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07062965

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~400 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:PF-07248144FulvestrantEverolimusExemestane

At a glance

Recruiting sites
122 of 202 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured over From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

202 sites across 97 states
Texas18
Colorado13
Connecticut10
Arizona8
California8
Maryland8
Minnesota8
Nevada6

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)