SKB264 Monotherapy or Combination Therapy: The interventions in this study comprised SKB264 monotherapy or combination therapy involving SKB264. The specific combination regimens were determined based on real-world clinical practice.
Study summary
This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/ HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender;
2. Patient must meet one of the following pathological diagnoses and classifications:
2.1) For TNBC Cohort: -Histological/cytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; -Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 2.2) For HR+/HER2- BC Cohort: -Histological/cytological confirmed of HR+/HER2- breast cancer from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.-Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection);
3. Plan to receive SKB264 monotherapy or combination therapy;
4. Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+/HER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease;
5. Voluntarily participate in the study, sign the informed consent form and demonstrate good compliance.
Exclusion Criteria:
1. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
2. Patients who are currently participating in other interventional clinical studies;
3. Known allergy to the investigational drug or any of its components;
4. Pregnant or lactating women;
5. Any situation that the researchers consider to interfere with the evaluation of the study drug or the safety of the subjects or the analysis of the study results, or any other situation that the researchers consider inappropriate to participate in this study.
Primary outcome measure(s)
Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer — Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.
Trial sites (19)
Facility
City
Region
Status
The Second Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
Chinese PLA General Hospital
Beijing
Beijing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Not Yet Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Not Yet Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Not Yet Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou
Henan
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Taihe Hospital
Shiyan
Hubei
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Not Yet Recruiting
The First People's Hospital of Changde City
Changde
Hunan
Recruiting
The first hospital of Jilin University
Changchun
Jilin
Recruiting
Yantai Yuhuangding Hospital
Yantai
Shandong
Recruiting
Zhongshan Hospital Fudan University
Shanghai
Shanghai Municipality
Recruiting
Shanxi Bethune Hospital
Taiyuan
Shanxi
Recruiting
Suining Central Hospital
Suining
Sichuan
Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo
Zhejiang
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.