Actively Recruiting
A Prospective, Open, Multicenter Single-arm Clinical Study of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Locally Advanced HER2-positive Breast Cancer
Led by Wang Ouchen · Updated on 2024-01-31
154
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a combination of docetaxel, carboplatin, Inetetamab, and Pyrotinib as a preoperative treatment for locally advanced HER2-positive breast cancer in women. This prospective, open, multi-center, single-arm trial aims to assess the treatment's effectiveness by focusing on total pathological complete response (tpCR) after surgery. The study also monitors long-term outcomes such as event-free survival, disease-free survival, distant metastasis-free survival, overall survival, and central nervous system disease-free survival. Additionally, the trial explores biomarkers related to treatment efficacy and evaluates the cardiotoxicity of Inetetamab and Pyrotinib.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years old
- ECOG performance status score of 0 to 1
- Histologically confirmed invasive breast cancer with primary tumor diameter greater than 2 cm
- Locally advanced tumor stage
- HER2-positive breast cancer confirmed by pathology
- Known hormone receptor status (estrogen and progesterone receptors)
- Adequate organ function including blood counts, liver and kidney tests within defined limits
- Left ventricular ejection fraction of 60% or higher
- Fridericia-corrected QT interval less than 470 msec
- For non-menopausal or non-sterilized women, agreement to use effective contraception during treatment and for 7 months after last dose
- Willingness to voluntarily join the study, sign informed consent, comply with treatment and follow-up
You will not qualify if you...
- Presence of metastatic (stage IV) breast cancer
- Prior anti-tumor therapy or radiotherapy for any malignant tumor except certain cured cancers
- Participation in other clinical trials involving anti-tumor treatments
- Major surgery unrelated to breast cancer within 4 weeks before enrollment or incomplete recovery from such surgery
- Severe heart disease or dysfunction, including low ejection fraction, uncontrolled arrhythmias, significant valve disease, recent heart attack, or poorly controlled high blood pressure
- Inability to swallow or absorb oral drugs
- History of allergy to study drug components or immunodeficiency conditions
- Pregnancy, lactation, or unwillingness to use contraception if of childbearing potential
- Serious other medical conditions or comorbidities interfering with planned treatment or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 months
Participants receive docetaxel, carboplatin, inetetamab, and pyrotinib as part of their treatment for locally advanced HER2-positive breast cancer.
Treatment cycles every 3 weeks with continuous daily oral pyrotinib
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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