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Clinical Trials List

Protocol NumberC4391022

NCT Number(ClinicalTrials.gov Identfier)NCT06105632

2023-12-15 - 2028-11-13

Phase III

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 3 Study of PF-07220060 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Participants Over 18 Years of Age 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

2025/08/20

Investigators and Locations

Principal Investigator Liang-Chih Liu 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張源清無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chiun-Sheng Huang 無

National Taiwan University 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 Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced or Metastatic Breast Cancer

Objectives

Evaluating PF-07220060 in combination with fulvestrant versus investigator choice of therapy (ICT) (i.e., fulvestrant alone or everolimus plus exemestane) in patients with hormone receptor (HR)-positive, human epidermal Growth factor receptor 2 (human epidermal growth factor receptor 2, HER2) negative advanced or metastatic breast cancer (mBC), and prior treatment with cyclin-dependent kinase (CDK) 4/ 6 Whether clinical outcomes can be improved among participants whose disease worsens after inhibitor treatment.

Test Drug

PF-07220060
Fulvestrant
Everolimus
Exemestane

Active Ingredient

PF-07220060
Fulvestrant
Everolimus
Everolimus
Exemestane

Dosage Form

Tablet
Solution for injection

Dosage

100 mg / Tablet
50 mg/mL
10 mg / Tablet
5 mg / Tablet
25 mg / Tablet

Endpoints

• PFS, defined as the time elapsed from the date of random assignment to the date of first documented disease progression, as determined by blinded independent central review based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 ( blinded independent central review (BICR), or death from any cause without progression of disease (PD), whichever occurs first
• OR determined by BICR

Inclution 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

-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

42 participants
Global

500 participants