Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer

The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）

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, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.

Inclusion Criteria:

1. Age 18 - 70 years, female
2. Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
3. Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
4. 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
5. Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
6. ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
7. The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
8. Adequate organ function;
9. Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
10. The patient voluntarily signs an informed consent form.

Exclusion Criteria:

1. Participated in other clinical trials within 4 weeks;
2. Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
3. During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
4. 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;
5. Evidence of central nervous system metastasis or leptomeningeal disease;
6. Individuals with a known history of allergies to the components of this medication regimen;
7. Pregnant or lactating women;
8. 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;
9. 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.