問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberMK-1022-016
NCT Number(ClinicalTrials.gov Identfier)NCT07060807
Active

2025-07-01 - 2035-12-31

Phase III

Recruiting7

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 Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/21

Investigators and Locations

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃柏翔 Division of Hematology & Oncology
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 李明陽 Division of Hematology & Oncology
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Hung Division of General Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林季宏 Division of Hematology & Oncology
National Taiwan University 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 Neoplasms

Objectives

主要目的： (1) 針對所有受試者，由BICR根據實體腫瘤反應評估標準第1.1版（RECIST 1.1）評估，比較patritumab deruxtecan（HER3-DXd）與TPC的PFS。 (2) 針對所有受試者，比較HER3-DXd與TPC的OS。 次要目的： (1) 針對所有受試者，由BICR根據RECIST 1.1評估，比較HER3-DXd與TPC的客觀反應率（ORR）。 (2) 針對所有受試者，由BICR根據RECIST 1.1評估，在反應持續時間（DOR）方面評估HER3-DXd與TPC的療效。 (3) 使用歐洲癌症研究治療組織30項核心生活品質問卷（EORTC-QLQ-C30），比較HER3-DXd與TPC在健康相關生活品質（HRQoL）方面自基期以來的平均值變化。 (4) 針對所有受試者，使用EORTC QLQ C30比較HER3-DXd與TPC在HRQoL方面的惡化前所經時間（TTD）。 (5) 評估HER3-DXd和TPC的安全性和耐受性。

Test Drug

注射劑

Active Ingredient

patritumab deruxtecan

Dosage Form

270

Dosage

100 mg/vial

Endpoints

(1) 針對所有受試者，由BICR根據實體腫瘤反應評估標準第1.1版（RECIST 1.1）評估，比較patritumab deruxtecan（HER3-DXd）與TPC的PFS。
(2) 針對所有受試者，比較HER3-DXd與TPC的OS。

Inclution Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent
Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)
Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:

Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or
Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization

Exclusion Criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has breast cancer amenable to treatment with curative intent
Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
Has any of the following: a pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has ≥Grade 2 peripheral neuropathy.
Has clinically significant corneal disease
Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening
Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    1000 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB