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Compares treatment options for Unrespectable Locally Advanced and or Metastatic HER2 Positive...
Official title JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06846437
What this study is testing
What is JSKN003?
JSKN003 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unrespectable locally advanced and or metastatic her2 positive breast cancer participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 5.Have received treatment regimen including trastuzumab (allowed marketed trastuzumab biosimilars) or inetetamab with radiologic or pathologic...
You likely can't join if
- 1\. Have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors or medenosin derivative 1 (DM1) or have relapsed after...
- 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...
- 6.Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.