Clinical trial NCT06551220: Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns
Official title: HER2 Heterogeneity and Its Impact on Benefit from Trastuzumab Deruxtecan in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
Trastuzumab Deruxtecan
HER2
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a multicenter, retrospective study led by the Sun Yat-sen University Cancer Center. A total of 16 centers are planned to participate in the study, and it aims to include patients with advanced or locally unresectable breast cancer who have received treatment with T-DXd.

Brief summary: The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:

- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?


Eligibility criteria: Inclusion Criteria:

* Patients with advanced or locally unresectable breast cancer;
* Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
* HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
* Measurable lesions with treatment response results that can be evaluated through imaging examinations;
* Able to follow up with the latest progression-free survival or overall survival.

Exclusion Criteria:

* Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
* Patients with missing pathological results for both primary and metastatic/recurrent lesions;
* Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
* Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
* Patients lost to follow-up after T-DXd treatment.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.
Other outcomes:
measure: Objective response rate (ORR)
timeFrame: From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
measure: Disease control rate (DCR)
timeFrame: From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
measure: Clinical benefit rate (CBR)
timeFrame: From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital, Fujian Medical University
state: Fujian
city: Dongguan
country: China
facility: The 10th Affiliated Hospital of Southern Medical University
state: Guangdong
city: Foshan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Foshan
country: China
facility: The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated Cancer Hospital, Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital of Shantou University
state: Guangdong
city: Shenzhen
country: China
facility: National Cancer Center Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Changde
country: China
facility: Changde Hospital, Xiangya School of Medicine, Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital, Hengyang Medical School, University of South China
state: Hunan
city: Hohhot
country: China
facility: Affiliated Cancer Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Shanghai
country: China
facility: Xinhua Hospital Afliated to Shanghai Jiaotong University
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
facility: Cancer Hospital of Shantou University Medical College
facility: The Affiliated Panyu Central Hospital, Guangzhou Medical University
Study officials:
affiliation: Sun Yat-sen University
name: Xiaoming Xie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: