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Clinical Trials List

Protocol NumberC4551002
NCT Number(ClinicalTrials.gov Identfier)NCT07062965
Active

2025-10-31 - 2029-02-04

Phase III

Not yet recruiting1

Recruiting5

ICD-10C79.81

Secondary malignant neoplasm of breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9198.81

Secondary malignant neoplasm of breast

An interventional, open-label, randomized, multicenter phase 3 trial comparing PF-07248144 plus Fulvestrant versus trial-designated therapy in adult participants with hormone receptor-positive, HER2-negative advanced/metastatic breast cancer whose disease had progressed following prior CDK4/6 inhibitor therapy.

  • Sponsor

    Pfizer Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/06

Investigators and Locations

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

Principal Investigator
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Chang Yu
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Breast cancer

Objectives

Compare the efficacy and safety of PF-07248144 plus Fulvestrant compared to the trial administrator-selected therapy in adult patients with hormone receptor-positive, HER2-negative advanced/metastatic breast cancer whose disease has progressed after prior CDK4/6 inhibitor therapy.

Test Drug

Everolimus 2.5 mg tablets
Everolimus tablets
Exemestane 25 mg
Fulvestrant Injection 250 mg per 5 mL solution for injection
PF-07248144

Active Ingredient

EVEROLIMUS
EVEROLIMUS
EVEROLIMUS
EXEMESTANE
FULVESTRANT
PF-07248144
PF-07248144

Dosage Form

Tablets
Tablets
Sugar-coated tablets
Injections
Film-coated tablets

Dosage

2.5 mg
5 mg
10 mg
25 mg
250mg / 5mL
25 mg
1mg
5 mg

Endpoints

PFS

Inclution Criteria

• Must be 18 years of age or older at the time of screening (or the minimum consent age as required by local regulations).

• Must have histologically confirmed HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, and be unsuitable for curative surgical resection or radiation therapy.

• Must have previously received a CDK4/6 inhibitor in one of the following situations, as described below:

i) CDK4/6i plus ET in A/mBC conditions; or

ii) Adjuvant CDK4/6i plus ET, with data showing PD/recurrence during CDK4/6i treatment or within 12 months after the last dose.

• In addition, participants are eligible to participate if they meet the following criteria:

• Have previously received CDK4/6i or ET as re-therapy for A/mBC, either as monotherapy or in combination therapy.

Note: fulvestrant or exemestane are permitted but not required.

• Have previously received therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene 1/2.

• Must provide a sufficient amount of representative formalin-fixed paraffin-embedded (FFPE) tumor tissue.

• Have a measurable disease, or a non-measurable disease limited to bones, as defined in RECIST version 1.1.

• Eastern Coast Cancer Clinical Research Consortium (ECOG) Performance Status (PS) of 0 or 1.

Note: Participants may be considered eligible under ECOG 2 if the trial administrator determines and the trial sponsor agrees that the participant has sufficient organ function, life expectancy, and meets other trial protocol eligibility criteria.

Exclusion Criteria

• Data showed that the Foundation One CDx (F1CDx) assay could detect deletions of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/AKT serine/threonine kinase 1 (AKT1)/phosphatase and tonotin homolog on chromosome 10 (PTEN) mutations in tissues.

• All participants without locally available F1CDx results will be tested prior to enrollment.

Note: Locally available F1CDx results may be used to establish eligibility.

• Previous treatment with more than two lines of systemic therapy for A/mBC.

• Previous targeted therapy for one or more PIK3CA, AKT1, or PTEN mutations.

• Previous chemotherapy for A/mBC, including antibody-drug complexes (ADCs). This trial did not exclude participants who had previously received chemotherapy as (leading) adjuvant therapy.

• Underwent major surgery within 4 weeks prior to randomization.

• Received systemic anticancer therapy or radiation therapy within 2 weeks prior to randomization.

• Have critical symptoms of organ metastasis or organ failure requiring immediate chemotherapy (including antibody-drug complex [ADC]), or be at risk of immediate life-threatening complications.

• Any medical or psychiatric condition that may increase the risk of participation or make the participant unsuitable for the trial.

• Known active, uncontrolled, or symptomatic central nervous system metastases, carcinomatous meningitis, or pia mater disease.

• Currently using or expected to require any prohibited foods, supplements, or concurrent medications (i.e., other anticancer therapies, other endocrine therapies, moderate or potent cytochrome P450 2C9 [CYP2C9] and P450 3A4/5 [CYP3A4/5] inhibitors and inducers).

• Kidney impairment, liver dysfunction, or hematological abnormalities.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    400 participants

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