Comparing JSKN003 and T-DM1 for advanced HER2-positive 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 clinical trial aims to compare the safety and efficacy of JSKN003 with trastuzumab emtansine (T-DM1) in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who have previously been treated with trastuzumab and taxane. It is a randomized, controlled, open-label, multicenter phase 3 study where participants will receive either JSKN003 or T-DM1 every three weeks until disease progression or other reasons for discontinuation. The study will assess the effectiveness of JSKN003 in improving patient outcomes compared to the standard treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Voluntarily agree to participate in the study and sign the informed consent.
* 2.Age≥18 years old.
* 3.Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology.
* 4.Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) by the pathology department of participating study center.
* 5.Have received treatment regimen including trastuzumab (allowed marketed trastuzumab biosimilars) or inetetamab with radiologic or pathologic progression/ relapse during the advanced stage, during neoadjuvant or adjuvant therapy, or within 12 months after treatment.
* 6.Previously treated with taxanes.
* 7.Had radiologic and/or pathologic progression or intolerance of the latest systemic anti-tumor therapy.
* 8.At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
* 9.ECOG PS of 0 - 1.
* 10.Patients with adequate organ and bone marrow functions.
* 11.Expected survival ≥ 3 months.
* 12.Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose of JSKN003 or T-DM1.

Exclusion Criteria:

* 1\. Have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors or medenosin derivative 1 (DM1) or have relapsed after receiving such therapy during or within 12 months after the adjuvant/neo-adjuvant setting or in the advanced stage.
* 2.History of any other malignant tumors within three years before randomization.
* 3.With uncontrollable serous effusion within 14 days before randomization, which requires frequent drainage or medical intervention.
* 4.Known contraindication to T-DM1or not suitable to receive JSKN003 or T-DM1 by investigator.
* 5.Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 (refer to NCI CTCAE 5.0) or baseline (excluding grade 2 alopecia, hyperpigmentation, simple laboratory test abnormalities, and other toxicity for a non-safety risk by investigators).
* 6.Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received palliative radiotherapy, endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization.
* 7.Major organ surgery within 28 days before randomization.
* 8.Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
* 9.The cumulative amount of previous exposure to anthracyclines has reached the pre-specified dosage.
* 10.History of LVEF \< 40% during prior anti-HER2 drug therapy or symptomatic congestive heart failure (CHF).
* 11.Serious or uncontrolled cardiovascular disease.
* 12.History of (non-infectious) interstitial lung disease/pneumonitis requiring therapy or grade ≥3 interstitial lung disease/ pneumonitis during previous anti-tumor treatments.
* 13.Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization.
* 14\. Active hepatitis B or hepatitis C.
* 15.History of immunodeficiency or HIV antibody test positive at screening.
* 16.Received a potent inhibitor of CYP3A4 within 14 days prior to randomization or during study treatment.
* 17.Pregnant or nursing females;
* 18.Other reasons enrolled in this clinical trial as considered unsuitable by the investigator.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Zhimin Shao, M.D. Organizational Affiliatio — Fudan University
• Study coordinator: Clinical Trials Information Group officer
• Email: ctr-contact@cspc.cn
• Phone: 86-0311-69085587

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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.