Real-world look at SKB264 in HER2-negative breast cancer that has come back or spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study plans to enroll about 500 patients divided into two cohorts: triple-negative breast cancer and HR+/HER2-negative breast cancer. Participants will receive SKB264 as a monotherapy or in combination, in a real-world setting outside of a controlled clinical trial. The study aims to describe how effective SKB264 is and how safe it is when used in routine clinical practice. Data will be collected from participating centers to characterize outcomes and tolerability in these cohorts. The exact study design and endpoints are not specified in the provided information.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting
• Taihe Hospital
  Shiyan, Hubei, China Recruiting
• The First People's Hospital of Changde City
  Changde, Hunan, China Recruiting

Study contacts

• Study coordinator: Xue Wang, M.D.
• Email: wxyxyuki@163.com
• Phone: 86-010-87787242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.