Actively Recruiting
The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-10-15
200
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.
CONDITIONS
Official Title
The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years old
- Pathological diagnosis confirming HER2 positive breast cancer
- Invasive breast cancer with local recurrence or metastasis, with local recurrence unsuitable for surgery
- No prior first-line anti-HER2 treatment or effective adjuvant anti-HER2 treatment stopped over 12 months ago
- ECOG performance status score between 0 and 2, expected survival of at least 6 months, and able to follow up
- At least one measurable lesion of 1 cm or larger per RECIST 1.1 criteria on CT or MRI
- Adequate organ function including blood counts, liver and kidney tests within specified limits
- Normal coagulation function with INR and APTT less than or equal to 1.5 times upper normal limit
- Left ventricular ejection fraction of 50% or higher
- QT interval corrected by Fridericia formula less than 470 msec on ECG
- No history of major organ diseases such as heart, lung, liver, kidney, or endocrine disorders
- Negative pregnancy test and use of reliable contraception for women of childbearing potential
- Ability and willingness to give informed consent and comply with study procedures
You will not qualify if you...
- Use of other clinical study drugs within 4 weeks before starting this study drug
- Any systemic anti-tumor treatment during recurrence/metastasis phase except endocrine therapy
- Prior anti-HER2 treatments other than trastuzumab, pertuzumab, or pyrotinib during adjuvant phase
- Disease progression during adjuvant trastuzumab or recurrence within 12 months post adjuvant treatment
- Symptomatic central nervous system metastases or leptomeningeal disease (stable brain metastases allowed)
- Only bone or skin lesions as target lesions
- Serious heart conditions including heart failure, systolic dysfunction (LVEF<50%), significant arrhythmias, heart valve disease, myocardial infarction, or uncontrolled hypertension
- Gastrointestinal diseases or active ulcers
- Active hepatitis B or C infection or cirrhosis
- Immunodeficiency diseases including HIV or history of organ transplantation
- Uncontrolled pleural effusion or ascites
- Serious comorbidities that interfere with treatment or study participation
- Other cancers within past 5 years except cured cervical or skin cancers
- Major surgery or trauma within 4 weeks before randomization
- Peripheral neuropathy grade 3 or higher
- Known allergies to study drug components
- Deemed unsuitable for systemic chemotherapy by investigators
- Pregnant or breastfeeding women unable to use effective contraception
- Other medical, social, or psychological conditions affecting safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat sen Memorial Hospital of Sun Yat sen University Shenzhen Shantou Central Hospital
Shanwei, Guangdong, China, 516621
Actively Recruiting
Research Team
J
Jianli Zhao, Doctor
CONTACT
Y
Ying Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here