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Clinical Trials List

Protocol NumberC4391025
NCT Number(ClinicalTrials.gov Identfier)NCT06465368
Active

2024-10-15 - 2025-10-31

Phase II

Recruiting5

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 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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 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 Shang-Wen Chen Division of Hematology & Oncology
Chi Mei Hospital, Liouying

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 Kuo-Ting Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Breast Cancer

Objectives

In postmenopausal women aged 18 years or older with hormone receptor-positive, HER2-negative breast cancer, the efficacy of PF-07220060 plus LETROZOLE was compared with that of LETROZOLE alone as a lead adjuvant therapy.

Test Drug

錠劑
錠劑

Active Ingredient

PF-07220060
LETROZOLE

Dosage Form

110
110

Dosage

100mg
2.5mg

Endpoints

The effects of PF-07220060 plus letrozole and letrozole alone on Ki-67 expression in tumors after 2 weeks of treatment were evaluated, respectively.

Inclution Criteria

Inclusion Criteria:

Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment)
Documented by estrogen receptor (ER) and/or progesterone receptor (PR)-positive disease by IHC or ISH
Participants must have Ki-67 score >/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC
Participants must be willing and able to undergo a baseline and Day 14 biopsy and must have an ECOG PS or 0 or 1.
Participants must be treatment naive for the treatment of BC and cannot have had prior treatment with any systemic therapy (e.g., chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents or use of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken.

Exclusion Criteria

Exclusion Criteria:

No prior systemic therapy, radiation, surgery, investigational therapy for treatment of breast cancer
Certain medical conditions in the previous 6 months, for example: myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism or other clinically significant episode of thromboembolism
Lab abnormalities outside protocol specified parameters
Gender-based Eligibility

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    118 participants

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