JSKN003 versus physician's choice chemotherapy for HER2-low advanced breast cancer

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 is a randomized, open‑label, multicenter phase III study enrolling 408 participants and using stratified block randomization to assign patients 1:1 to JSKN003 monotherapy or investigator's choice single‑agent chemotherapy. Eligible participants have HER2‑low disease (IHC 1+ or 2+/ISH‑) and have progressed after one or two prior lines of chemotherapy for recurrent or metastatic disease. The control options include capecitabine, gemcitabine, vinorelbine, docetaxel, albumin‑bound paclitaxel, or eribulin as single agents. The trial measures efficacy and safety outcomes to compare the experimental agent against commonly used chemotherapy options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.

  2\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female.

  3\. Unresectable locally recurrent or metastatic breast cancer, previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-, previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+.

  4\. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage.

  5\. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status.

  6\. Documented radiographic disease progression (during or after the most recent treatment).

  7\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.

  8\. Expected survival ≥ 3 months. 9. ECOG score of 0 or 1 within 14 days prior to administration. 10. Female subjects of childbearing potential or male subjects of fertile partner consent to use highly effective contraception from the signing of informed consent.

  11\. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria.

  12\. Have sufficient elution of previous treatment before administration.

Exclusion Criteria:

* 1\. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.

  2\. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration.

  4\. Selection of the control drug by the investigator who is not suitable for the protocol prescribed.

  5\. Previous use of antibody conjugates containing topoisomerase I inhibitors. 6. There is a third gap fluid that cannot be controlled by drainage, etc. 7. Previous or current interstitial pneumonia/lung disease requiring systemic hormone therapy.

  8\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug.

  9\. Previous or current autoimmune disease. 10. Have uncontrolled comorbidities. 11. The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0).

  12\. History of previous immunodeficiency. 13. History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation.

  14\. Other conditions that the investigators believe will affect the safety or adherence to drug treatment in this study, including but not limited to psychiatric disorders, alcohol or drug abuse.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting
• Peking University Cancer Hospital
  Beijing, China Recruiting
• The First Affiliated Hospital of China Medical University
  Beijing, China Recruiting
• The First People's Hospital of Changde
  Changde, China Recruiting
• Hunan Cancer Hospital
  Changsha, China Recruiting
• Affiliated Hospital of Chengde Medical University
  Chengde, China Recruiting

+37 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Erwei Song — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Erwei Song
• Email: songew@mail.sysu.edu.cn
• Phone: 020-81332507

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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.