Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06832904
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy — DRUG
    Receive four neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) , nab-paclitaxel (260 mg/m2) and carboplatin（AUC=5）every 3 weeks.

Study Details

This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR）and clinical complete response（cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR). The study also observes the incidence and types of adverse events.

Key Dates

First listed
Feb 18, 2025
Start date
Dec 3, 2024
Status verified
Dec 2024
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single-arm

Primary Outcome Measure

pathologic complete response（pCR） [ Time Frame: 2 years ]

Central Contacts

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