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Hengrui pirotinib maleate tablets combined treatment of breast cancer phase III clinical trial reached the primary endpoint

 Last Update: 2021-06-18
 Source: Internet
 Author: User

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Today, Hengrui Medicine issued an announcement stating that the company's pirotinib maleate tablets combined with trastuzumab plus docetaxel for preoperative treatment of early or locally advanced HER2-positive breast cancer are randomized, double-blind, parallel controlled, In a multi-center phase III clinical study, the main research endpoint-total pathological complete remission (tpCR) reached the pre-specified superiority standard
.

The results of the study show that for early or locally advanced HER2-positive breast cancer, neoadjuvant therapy combined with pirotinib on the basis of docetaxel and trastuzumab can significantly increase the tpCR rate of patients
.

The company will submit a pre-market communication application to the Drug Evaluation Center of the State Drug Administration in the near future

It is reported that this study (HR-BLTN-III-NeoBC) is an evaluation of pirotinib maleate tablets combined with trastuzumab plus docetaxel versus placebo combined with trastuzumab plus docetaxel A randomized, double-blind, parallel-controlled, multi-center phase III clinical study on the effectiveness and safety of preoperative treatment of early or locally advanced HER2-positive breast cancer (NCT03588091), with Professor Wu Jiong from the Cancer Hospital of Fudan University as the main investigator , 17 centers across the country participated together
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The primary research endpoint is the total pathological complete response (tpCR) assessed by the independent review committee (IRC) through pathology, and the secondary research endpoints include tpCR assessed by the pathologist of the participating center, event-free survival time (EFS), and disease-free survival time (DFS), survival time without distant metastasis (DDFS), objective response rate (ORR) and safety

A total of 355 subjects were enrolled in this study, and they were randomly enrolled according to 1:1, and received pyrrotinib combined with trastuzumab plus docetaxel treatment group (experimental group) or placebo combined with trastuzumab Add docetaxel treatment group (control group), every 21 days is a treatment cycle, a total of 4 cycles
.

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