🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06993506
Recruiting Observational

Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer

NCT06993506 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Observational
Started
2026-05-28
Last updated
2026-08-18

Condition(s) studied

HER2-negative Breast CancerRecurrenceMetastasis

Investigational drug(s) / intervention(s)

SKB264 Monotherapy or Combination TherapyAll Sacituzumab tirumotecan trials (60) →All Combination Therapy trials (4) →

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)

Trial sites (19)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06993506 on ClinicalTrials.gov ↗ ← All trials in China