Status:
NOT_YET_RECRUITING
Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer Stage IV
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab...
Eligibility Criteria
Inclusion
- Age 18 - 70 years, female
- Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
- Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
- Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
- Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
- ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
- The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
- Adequate organ function;
- Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
- The patient voluntarily signs an informed consent form.
Exclusion
- Participated in other clinical trials within 4 weeks;
- Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
- During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
- Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
- Evidence of central nervous system metastasis or leptomeningeal disease;
- Individuals with a known history of allergies to the components of this medication regimen;
- Pregnant or lactating women;
- Left ventricular ejection fraction\<50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;
- The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06578299
Start Date
August 30 2024
End Date
August 30 2027
Last Update
August 29 2024
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