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Clinical Trials List

Protocol NumberC4391024

NCT Number(ClinicalTrials.gov Identfier)NCT06760637

Active

2025-02-11 - 2038-02-19

Phase III

Recruiting8

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/07/10

Investigators and Locations

Principal Investigator

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 沈士哲無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YEN-SHEN LU 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jih-Hsiang Lee 無

National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Hung 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰無

Koo Foundation Sun Yat-Sen Cancer Center

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

The study aimed to evaluate whether PF-07220060 plus letrozole, as a substitute for cyclin-dependent kinase (CDK) 4/6 inhibitors (CDK4/6i) (with trial administrator options of abemaciclib, palbociclib, or ribociclib), plus letrozole, could improve clinical outcomes in participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (a/mBC) who had not previously received any systemic anticancer therapy for advanced/metastatic disease.

Test Drug

錠劑
錠劑
膠囊劑
錠劑
錠劑
錠劑

Active Ingredient

Atirmociclib (PF-07220060)
Palbociclib
Abemaciclib
Ribociclib
Letrozole

Dosage Form

110
110
909
110
110
110

Dosage

100mg
100mg
125mg
75mg
100mg
150mg
50mg
200mg
2.5mg

Endpoints

比較 PF-07220060 合併 letrozole (A 組) 與 CDK4/6i (試驗主持人選用：abemaciclib、palbociclib 或 ribociclib) 合併 letrozole (B 組) 在無惡化存活期 (progression-free survival, PFS) 方面的療效

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
Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1

Exclusion Criteria

Exclusion Criteria:

In visceral crisis at risk of immediately life-threatening complications in the short term.
Current or past history of central nervous system metastases.
Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

The Estimated Number of Participants

Taiwan

60 participants
Global

1020 participants