Clinical Trials List
Protocol NumberWO46069
NCT Number(ClinicalTrials.gov Identfier)NCT07413939
Active
2026-03-01 - 2032-12-31
Phase II/III
Not yet recruiting1
A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases
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Trial Applicant
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- 林柏翰 無
- MING-YANG WANG 無
- 楊明翰 無
- WEI-LI MA 無
- 謝正彥 無
- YEN-SHEN LU 無
- Wei-Wu Chen 無
- 陳怡君 無
- 林季宏 無
- 黃柏翔 無
- 李佳真 無
- 羅喬 無
- 陳怡君 無
- 魏以宣 無
Co-Principal Investigator
- 林燕淑 無
- 邱仁輝 無
- 郭懿萱 無
- 陳彥蓁 無
- 馮晉榮 無
- Chi-Cheng Huang 無
- Ta-Chung Chao 無
- Chun-Yu Liu 無
- Yi-Fang Tsai 無
- 鄭涵方 無
- 賴亦貞 無
- Jiun-I Lai 無
Co-Principal Investigator
- 沈士哲 無
- Wen-Chi Shen 無
- 阮昱翔 無
- Yung-Chang Lin 無
- 秦嗣騏 無
- Wen-Ling Kuo 無
- Shin-Cheh Chen 無
- Mengting Peng 無
- Chi-Chang Yu 無
- Chan-Keng Yang 無
- Chun-Hsiu Liu 無
Co-Principal Investigator
- 王國鐘 無
- Kuan-Der Lee 無
- ZHENG-WEI ZHOU 無
- 林慈恩 無
- Huey-En Tzeng 無
- 楊陽生 無
- I-Chen Tsai 無
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
HER2-positive Breast Cancer
Objectives
本試驗的目的在於比較兩種不同劑量等級的RO7771950併用trastuzumab和
capecitabine，與tucatinib併用trastuzumab和capecitabine，對於晚期乳癌患
者所產生好或壞的影響。具體而言，本試驗將評估何種劑量等級的RO7771950可
用於治療HER2陽性乳癌患者，以及相較於tucatinib併用trastuzumab和
capecitabine，RO7771950併用trastuzumab和capecitabine是否能降低您的乳癌
惡化之風險。
本試驗特別關注腦部區域(中樞神經系統)，因為治療該區域的癌症極具挑戰性。
腦部有一道保護屏障，經常阻擋藥物進入。本試驗將評估兩種治療方式在治療可
能已擴散至腦部區域的癌症，以及預防癌症擴散至腦部的效果。
Test Drug
膜衣錠
膜衣錠
注射液劑
凍晶注射劑
膜衣錠
膜衣錠
腸溶錠
膜衣錠
膜衣錠
注射液劑
凍晶注射劑
膜衣錠
膜衣錠
腸溶錠
膜衣錠
Active Ingredient
capecitabine
capecitabine
trastuzumab
tucatinib
tucatinib 150mg
RO7771950
capecitabine
trastuzumab
tucatinib
tucatinib 150mg
RO7771950
Dosage Form
116
116
27D
243
116
116
115
116
116
27D
243
116
116
115
116
Dosage
500 mg/tablet
150 mg/tablet
600 mg/5 ml
150 mg/vial
50mg/tablet
150mg/tablet
200 mg/tablet
200 mg/tablet
150 mg/tablet
600 mg/5 ml
150 mg/vial
50mg/tablet
150mg/tablet
200 mg/tablet
200 mg/tablet
Endpoints
評估RO7771950 併用HX(trastuzumab 和capecitabine)相較於
tucatinib 併用HX(trastuzumab 和capecitabine)之療效
tucatinib 併用HX(trastuzumab 和capecitabine)之療效
Inclution Criteria
Inclusion Criteria:
Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory.
Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.
Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.
At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.
Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not locally accessible at screening, or if there is a prospectively documented clinical contraindication.
Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is > 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI/MBC is not permitted.
Has protocol-defined adequate organ and bone marrow function.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Baseline left ventricular ejection fraction (LVEF) ≥ 50%.
Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory.
Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.
Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.
At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.
Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not locally accessible at screening, or if there is a prospectively documented clinical contraindication.
Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is > 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI/MBC is not permitted.
Has protocol-defined adequate organ and bone marrow function.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Baseline left ventricular ejection fraction (LVEF) ≥ 50%.
Exclusion Criteria
Exclusion Criteria:
Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.
Known active/untreated hepatitis B or C or chronic liver disease.
Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events/interventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.
Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.
Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.
Known active/untreated hepatitis B or C or chronic liver disease.
Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events/interventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.
Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
650 participants
