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OncoMatch/Clinical Trials/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.

Is NCT07062965 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PF-07248144 and Fulvestrant for breast cancer.

Phase 3RecruitingPfizerNCT07062965Data as of May 2026

Treatment: PF-07248144 · Fulvestrant · Everolimus · ExemestaneThe purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. HR-positive breast cancer cells have proteins on their surface called receptors that bind to hormones like estrogen and progesterone (female sex hormones). These hormones can promote the growth of cancer cells. HER2-negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2-negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the type where the cancer cells spread from one part of the body to another. This study is seeking for participants whose breast cancer has gotten worsen after receiving cyclin dependent kinase (CDK) 4/6 inhibitor-based therapy. Half of participants in this study will receive their usual study treatment, everolimus with endocrine therapy (either exemestane or fulvestrant) for HR-positive/HER2-negative advanced or metastatic breast cancer (A/mBC). The study doctor will discuss which hormone therapy is right for the participant before treatment begins. PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle. Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic. Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle. The study will compare the experiences of people receiving PF-07248144 in combination with fulvestrant to those of the people who do not. This will help see if PF-07248144 in combination with fulvestrant is safe and effective.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: PIK3CA alteration

Documented detectable PIK3CA/AKT1/PTEN alterations in tissue [excluded]

Required: AKT1 alteration

Documented detectable PIK3CA/AKT1/PTEN alterations in tissue [excluded]

Required: PTEN alteration

Documented detectable PIK3CA/AKT1/PTEN alterations in tissue [excluded]

Disease stage

Metastatic disease required

locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines
Min 1 prior line

Must have received: CDK4/6 inhibitor — advanced or metastatic

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

Cannot have received: chemotherapy

Exception: chemotherapy in the (neo)adjuvant setting is allowed

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.

Lab requirements

Blood counts

hematologic abnormalities excluded

Kidney function

renal impairment excluded

Liver function

hepatic dysfunction excluded

Renal impairment, hepatic dysfunction, or hematologic abnormalities

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Ironwood Cancer & Research Centers · Chandler, Arizona
  • Ironwood Cancer & Research Centers · Gilbert, Arizona
  • Ironwood Cancer & Research Centers · Glendale, Arizona
  • Ironwood Cancer & Research Centers · Goodyear, Arizona
  • Ironwood Cancer & Research Centers · Mesa, Arizona

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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