Combining Pyrotinib and Fulvestrant for Breast Cancer Treatment
Author Information
Author(s): Zhao Jianli, Yu Yunfang, Ren Wei, Ding Linxiaoxiao, Chen Yongjian, Yuan Peng, Yue Jian, Yang Yaping, Zou Guorong, Chen Tao, Chai Jie, Zhang Li, Wu Wenjing, Zeng Yinduo, Gui Xiujuan, Cai Yangyang, Luo Simin, Yuan Zhongyu, Zhang Kang, Yao Herui, Wang Ying
Primary Institution: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Hypothesis
Can the combination of pyrotinib and fulvestrant improve outcomes in HR-positive/HER2-positive metastatic breast cancer patients who have failed trastuzumab treatment?
Conclusion
The combination of pyrotinib and fulvestrant shows promising antitumor activity and acceptable safety in patients with HR-positive/HER2-positive metastatic breast cancer.
Supporting Evidence
- The median progression-free survival (PFS) was 18.2 months.
- The overall survival (OS) rate at 3 years was 75.2%.
- The objective response rate (ORR) was 32.5%.
- No grade 4 or higher treatment-related adverse events were reported.
Takeaway
This study tested a new medicine combination for breast cancer and found it helps many patients feel better without serious side effects.
Methodology
This was a multicenter, single-arm, phase II clinical trial evaluating the efficacy and safety of pyrotinib combined with fulvestrant in patients with HR-positive/HER2-positive metastatic breast cancer.
Potential Biases
Potential bias due to the lack of a control group and small sample size.
Limitations
The study is a single-arm trial without a control group and involves a relatively small patient cohort.
Participant Demographics
Median age was 55 years; 43% had visceral metastasis and 13% had brain metastasis.
Statistical Information
P-Value
p<0.001
Confidence Interval
95% CI, 11.9–31.1
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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