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A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer

ConditionBreast Neoplasm Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWang Ouchen

About this trial

This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-75 years old;

ECOG score 0-1;

Breast cancer meets the following criteria: Histologically confirmed invasive breast cancer, primary tumor diameter > 2 cm as determined by standard evaluation methods at the research center; tumor stage: locally advanced;

HER2 expression-positive breast cancer confirmed by pathological examination;

Disqualifiers

IV (metastatic) breast cancer;

Received anti-tumor therapy or radiotherapy for any malignant tumor in the past, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;

Receiving anti-tumor therapy in other clinical trials at the same time, including endocrine therapy, bisphosphonate therapy or immunotherapy;

Received major surgical operations unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical operations;

Trial design

Design model

Single group

Treatments tested in this trial

  • Docetaxel

    Drug

    75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

  • Carboplatin

    Drug

    AUC=6 min/mL iv 3-weekly

  • Inetetamab

    Drug

    8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

  • Pyrotinib

    Drug

    400mg orally daily

Treatment groups

154 Participants
are divided into 1 treatment group
Group A: treatment armExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

tpCR

total pathological complete response

Time frame
Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 6)

Secondary outcomes

1

EFS

Event-free survival

Time frame
Randomization up to a maximum of 329 weeks
2

DFS

Disease-free survival

Time frame
Randomization up to a maximum of 329 weeks
3

DDFS

Distant disease free survival

Time frame
Randomization up to a maximum of 329 weeks
4

OS

Overall survival

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wang Ouchen

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Sponsor institution

Source ClinicalTrials.gov
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