Comparing disitamab vedotin and pyrotinib to standard treatment for HER2-positive 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 phase III clinical trial aims to evaluate the efficacy and safety of disitamab vedotin combined with pyrotinib compared to the standard first-line treatment of paclitaxel with trastuzumab and pertuzumab (THP) in patients with newly diagnosed HER2-positive metastatic breast cancer. Participants will receive the experimental treatment for 6-8 cycles, followed by maintenance therapy with trastuzumab. The study also seeks to explore how biomarkers may influence the clinical outcomes of the treatments. It is a multicenter, randomized, double-blind controlled trial designed to provide robust data on treatment effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult female patients (age 18-75 years) with metastatic breast cancer confirmed by pathology or imaging;
2. Pathologically confirmed HER2 positive (definition: Immunohistochemistry(IHC) 3+, or IHC 2+ and Fluorescent In Situ Hybridization(FISH) amplification);
3. No previous chemotherapy regimen for metastatic breast cancer;
4. At least one measurable lesion exists (Response Evaluation Criteria in Solid Tumors(RECIST) 1.1);
5. Eastern Cooperative Oncology Group(ECOG) performance status score ≤ 2 and expected survival of not less than 3 months;
6. 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 that, in the judgment of the investigator, is not considered a risk to the safety of the patient);
7. Patients with adequate organ function before enrollment:

   1. White Blood Cell (WBC) ≥ 3.0 x 10\^9/L;
   2. Neutrophil granulocyte (ANC) ≥1.5 x 10\^9/L;
   3. Platelet (PLT) ≥70×10\^9/L;
8. Liver, kidney, and cardiac function tests are essentially normal (based on the normal values in the laboratory of each study center):

   1. Total bilirubin (TBIL) ≤ 3 x Upper Limit of Normal (ULN);
   2. Alanine aminotransferase (ALT/AST) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases);
   3. serum creatinine ≤ 1.5 x ULN or creatinine clearance (Ccr) ≥ 60 ml/min;
9. . Normal cardiac function;

   1. Left ventricular ejection fraction (LVEF) ≥ 55%;
   2. QT-interval corrected with Fridericia (QTcF) ≤ 470ms;
10. Hormone receptor status is clear;
11. 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 drug;
12. Able to understand the study process, voluntarily participate in this study, and sign an informed consent form.

Exclusion Criteria:

1. Pathology suggestive of HER2 negativity (IHC 2+ and FISH-, or IHC 1+);
2. Patients with known hypersensitivity to the active ingredient or other components of the study drug;
3. 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;
4. 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 of the subject (e.g., uncontrolled heart disease, high blood pressure, active or uncontrolled infections, active hepatitis B virus infection).

Where it's running

• Sun Yat-sen Memorial Hospital,Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• RC48 with bevacizumab or pyrotinib for HER2-positive metastatic breast cancer after T-Dxd failure

  This trial will try RC48 together with either bevacizumab or pyrotinib in adults with HER2-positive metastatic breast cancer whose disease has progressed after trastuzumab deruxtecan (T-Dxd).

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07065435

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

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  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Dalpiciclib with Anti-HER2 and Endocrine Therapy as Maintenance in HR+/HER2+ Metastatic Breast Cancer

  A phase II trial tests whether adding dalpiciclib to anti-HER2 therapy and endocrine therapy can help advanced HR+/HER2+ breast cancer stay under control after initial treatment.

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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.