NCT05871918

A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer

A Multicenter, Randomized, Open, Phase III Trial of ddEC-THP（Epirubicin，Cyclophosphamide，TAX(Taxol)，Trastuzumab，Pertuzumab）vs Evaluating the Efficacy and Safety of TCHP （CBP(Carboplatin),TXT(Taxotere),Trastuzumab，Pertuzumab）Neoadjuvant Therapy for HER2-positive Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 832 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to assess the efficacy and safety of anthracycline-containing ddEC-THP intensive regimen and an anthracycline-free TCbHP neoadjuvant therapy for HER2-positive breast cancer

Detailed description

A Multicenter, Randomized, Open, Phase III，The study is being conducted to assess the efficacy and safety of anthracycline-containing ddEC-THP intensive regimen and an anthracycline-free TCbHP neoadjuvant therapy for HER2-positive breast cancer,Subjects will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.

Conditions

• HER-2 Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	TCbHP VS ddEC-THP	The efficacy was evaluated every two cycles, and the effective patients (CR, PR, SD) were treated with surgery after 6 cycles. If treatment does not work, change the treatment plan according to the clinician's decision.

Timeline

• Start date: 2022-10-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-05-23
• Last updated: 2023-05-23

Locations

1 site across 1 country: China