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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

Recruiting6

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 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/08

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 康乃文 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung
National Taiwan University Hospital

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

Film-coated tablets
Injection
Sugar-coated tablets
Tablets
Tablets

Active Ingredient

PF-07248144
FULVESTRANT
EXEMESTANE
EVEROLIMUS

Dosage Form

116
270
119
110
110

Dosage

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

Endpoints

PFS

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    400 participants

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