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Clinical Trials List

Protocol NumberC4391022
NCT Number(ClinicalTrials.gov Identfier)NCT06105632
Active

2023-12-15 - 2028-11-13

Phase II

Recruiting7

ICD-10Z85.3

Personal history of malignant neoplasm of breast

ICD-9V10.3

Personal history of malignant neoplasm of breast

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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

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 Division of General Surgery
Taipei Veterans General Hospital

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 Liang-Chih Liu Division of General Surgery
China Medical University 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

Advanced or Metastatic Breast Cancer

Objectives

The aim of this trial was to evaluate whether PF-07220060 in combination with fulvestrant, relative to the investigator's choice of therapy (ICT) (i.e., fulvestrant alone, or everolimus in combination with exemestane), could improve clinical outcomes in participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (mBC) whose disease had worsened after prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors.

Test Drug

錠劑
注射液
錠劑
錠劑

Active Ingredient

PF-07220060
FULVESTRANT
EVEROLIMUS
EXEMESTANE

Dosage Form

110
279
110
110

Dosage

100mg
50 mg/mL (2 × 250 mg/5 mL injection)
10mg, 5mg
25mg

Endpoints

The trial administrator determines PFS as the time elapsed from the randomization date to the date of first recorded disease progression. The determination is based on the trial administrator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.l., or death from any cause without disease progression (PD), whichever occurs first.

Inclution Criteria

Inclusion Criteria:

Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
Documented HER2-negative tumor
Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

Exclusion Criteria

Exclusion Criteria:

Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
In visceral crisis at risk of immediately life-threatening complications in the short term.
Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
Prior treatment with any of the following:
Everolimus or investigational anti-cancer agents in any setting
Prior chemotherapy in the advanced setting
Radiation within 2 weeks of randomization
Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    264 participants

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