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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study a treatment called Sacituzumab Tirumotecan (SKB264) for patients with HER2-negative breast cancer that has come back or spread to other parts of the body. The trial will enroll up to 500 people and is divided into two groups: one for patients with triple-negative breast cancer (TNBC) and another for those with hormone receptor-positive, HER2-negative breast cancer (HR+/HER2- BC). The goal is to see how effective and safe SKB264 is when given alone or in combination with other treatments in real-life situations.

To be eligible for this study, patients must be at least 18 years old and have been diagnosed with either type of HER2-negative breast cancer. They should have had no more than two previous treatments for their advanced cancer and must be planning to receive SKB264 treatment. Participants can expect to be carefully monitored throughout the study to assess how well the medication works and any side effects they may experience. It’s important to note that the study is not currently recruiting, and those interested should be aware of specific criteria that could exclude them from participating, such as having other cancers or being pregnant.

Gender

ALL

Eligibility criteria

• 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.