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Compares treatment options for HER2-positive Metastatic Breast Cancer
Official title Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
ClinicalTrials.gov ID: NCT06278870
What this study is testing
What is disitamab vedotin?
disitamab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive metastatic breast cancer.
Also referred to as RC-48.
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
- The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are: Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.
- 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 to 75, women only
You may be able to join if
- Adult female patients (age 18-75 years) with metastatic breast cancer confirmed by pathology or imaging;
- Pathologically confirmed HER2 positive (definition: Immunohistochemistry(IHC) 3+, or IHC 2+ and Fluorescent In Situ Hybridization(FISH)...
- No previous chemotherapy regimen for metastatic breast cancer;
- At least one measurable lesion exists (Response Evaluation Criteria in Solid Tumors(RECIST) 1.1);
- Eastern Cooperative Oncology Group(ECOG) performance status score ≤ 2 and expected survival of not less than 3 months;
You likely can't join if
- Pathology suggestive of HER2 negativity (IHC 2+ and FISH-, or IHC 1+);
- Patients with known hypersensitivity to the active ingredient or other components of the study drug;
- Patients during pregnancy or lactation, patients with childbearing potential tested positive in a baseline pregnancy test, or patients unwilling to...
- Patients not eligible for this study judged by the investigator, a pre-existing disease or condition that may interfere with participation in the...
See the full eligibility criteria
- Adult female patients (age 18-75 years) with metastatic breast cancer confirmed by pathology or imaging;
- Pathologically confirmed HER2 positive (definition: Immunohistochemistry(IHC) 3+, or IHC 2+ and Fluorescent In Situ Hybridization(FISH) amplification);
- No previous chemotherapy regimen for metastatic breast cancer;
- At least one measurable lesion exists (Response Evaluation Criteria in Solid Tumors(RECIST) 1.1);
- Eastern Cooperative Oncology Group(ECOG) performance status score ≤ 2 and expected survival of not less than 3 months;
- Prior treatment-related toxicity at enrollment must have resolved to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) (version 5.0) ≤ 1 degree (except for alopecia or other toxicity...
- Patients with adequate organ function before enrollment:
- White Blood Cell (WBC) ≥ 3.0 x 10\^9/L;
- Neutrophil granulocyte (ANC) ≥1.5 x 10\^9/L;
- Platelet (PLT) ≥70×10\^9/L;
- Liver, kidney, and cardiac function tests are essentially normal (based on the normal values in the laboratory of each study center):
- Total bilirubin (TBIL) ≤ 3 x Upper Limit of Normal (ULN);
- Alanine aminotransferase (ALT/AST) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases);
- serum creatinine ≤ 1.5 x ULN or creatinine clearance (Ccr) ≥ 60 ml/min;
- . Normal cardiac function;
- Left ventricular ejection fraction (LVEF) ≥ 55%;
- QT-interval corrected with Fridericia (QTcF) ≤ 470ms;
- Hormone receptor status is clear;
- Female patients of childbearing potential who have a negative pregnancy test and agree to use an effective non-hormonal method of contraception during treatment and for at least 6 months after the last dose of the test...
- Able to understand the study process, voluntarily participate in this study, and sign an informed consent form.
- Pathology suggestive of HER2 negativity (IHC 2+ and FISH-, or IHC 1+);
- Patients with known hypersensitivity to the active ingredient or other components of the study drug;
- Patients during pregnancy or lactation, patients with childbearing potential tested positive in a baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial;
- Patients not eligible for this study judged by the investigator, a pre-existing disease or condition that may interfere with participation in the study or any serious medical disorder that may interfere with the safety...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.