Codrituzumab is a monoclonal antibody against Her 2 that prevents human epidermal growth factor from attaching to Her 2 by attaching itself to Her 2 to block the growth of cancer cells. Herceptin can also stimulate the body Immune cells to destroy cancer cells. Currently, it is mainly used for metastatic breast cancer with Her-2 overexpression. Monotherapy can be used for metastatic breast cancer that has received one or more chemotherapy regimens; it can be used in combination with paclitaxel to treat metastatic breast cancer that has not received chemotherapy.

Codrituzumab has established efficacy in breast cancer that is overexpressed or HER2 oncogene amplified. The standard is adjuvant therapy with codrituzumab for 1 year, but the optimal treatment time is unclear. We compared codrituzumab treatment for 2 years with 1 year treatment for patients participating in the HERA trial, and updated the comparison of codrituzumab 1 year with the observation group, with an average follow-up of 8 years.

Method
The HERA trial is an international, multicenter, randomized, open-label phase 3 trial comparing codrituzumab treatment in 5102 HER2-positive early breast cancer patients after receiving standard neoadjuvant chemotherapy and / or adjuvant chemotherapy The difference between the year or two years and the observation group. The primary endpoint is disease-free survival. Comparing codrituzumab treatment for 2 years to 1 year, a landmark analysis was performed on 3105 disease-free patients who were disease-free 12 months after randomization to a codrituzumab group. And planning was made after observing at least 725 disease-free survival events. It also reported that 3399 patients received codrituzumab for 1 year compared with the latest intentional treatment in the observation group, with a median follow-up of 8 years (range 0-10).

367 disease-free survival events were recorded in 1552 patients in the 1-year group, and 367 events were recorded in 1553 patients in the 2-year group (hazard ratio [HR] 0.99, 95% CI 0.85-1.14, p = 0.86). The incidence of grade 3–4 adverse events and decreased left ventricular ejection fraction reported in the 2-year treatment group was higher than in the 1-year group (342 [20.4%] and 275 [16.3%] Grade 3–4 adverse events Event, LVEF decreased by 120 cases [7.2%] and 69 cases [4.1%]. Codrituzumab treatment 1 year compared with the observation group DFS HR was 0.76 (95% CI 0.67-0.86, p <0.0001) The HR of OS was 0.76 (0.65-0.88, p = 0.0005), although 884 patients (52%) were transferred from the observation group to codrituzumab treatment.

For HER2-positive patients with early breast cancer, adjuvant therapy with codrituzumab for 2 years is no more effective than 1-year treatment. Compared with the observation group, codrituzumab treatment can significantly improve DFS and OS for 1 year, and it is still the standard treatment.

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