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.
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
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;
Single group
Inetetamab and Paclitaxel ± Pertuzumab
DrugInetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
PFS
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) or stable disease（SD）\>6 months determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart.
Overall Survival (OS)
OS is defined as the time from the participant's first dose of study treatment to the date of death.
Number of Participants With Adverse Events (AEs)
Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).
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