Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06278870

Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial

HER2-positive Metastatic Breast Cancer Clinical Trial

Official title:
Disitamab Vedotin in Combination With Pyrotinib Versus THP in the First-line Treatment for HER2-positive Advanced Breast Cancer, a Multicentre, Randomized, Double-blind Controlled, Phase III Trial

Clinical Trial Summary

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. - Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment. Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab. Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06278870
Study type Interventional
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact
Status Recruiting
Phase Phase 3
Start date September 6, 2023
Completion date June 30, 2031
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04692831 - Testing a New Imaging Agent to Identify Cancer Phase 1
Recruiting NCT04385563 - A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC. Phase 3
Terminated NCT04778982 - Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
Active, not recruiting NCT03417544 - Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC Phase 2
Recruiting NCT04319757 - ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors Phase 1
Recruiting NCT05188495 - Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
Recruiting NCT05583110 - Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT06298084 - Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd Phase 1/Phase 2
Recruiting NCT05650879 - ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03979339 - Feasibility of a New Technology for Isolating Circulating Tumour Cells N/A
Recruiting NCT05042791 - A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases Phase 2
Active, not recruiting NCT05555251 - BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors Phase 1/Phase 2
Withdrawn NCT04602117 - ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer Phase 1
Recruiting NCT05959291 - Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer N/A
Recruiting NCT06299852 - Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer N/A
Completed NCT06305702 - Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer
Completed NCT02605915 - Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer Phase 1
Recruiting NCT05868226 - PRE-I-SPY Phase I/Ib Oncology Platform Program Phase 1
Recruiting NCT05800275 - Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease Phase 2
Recruiting NCT05036252 - Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity