Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
The international treatment guidelines now include recommendations for the use of CDK 4/6
inhibitors in combination with hormone agents for the treatment of postmenopausal women with
hormone-receptor-positive/HER2-negative ABC as the first-line standard therapy in endocrine
sensitive patients.
Nevertheless, it is generally thought that chemotherapy is associated with greater and
earlier tumor response, especially in case of high burden of disease. In a retrospective
analysis of real-world clinical practice (2002-2012) from US, only 60% of patients initiated
ET as the first treatment following metastatic diagnosis . In the real-life world of China, a
large number of HR+/HER2- ABC patients with non-visceral crisis also received chemotherapy in
first-line treatment, even though the ORR is similar compared with CDK4/6 inhibitors with
endocrine therapy. Zhejiang Cancer Hospital retrospective analysis of 5 cases of advanced
breast cancer first-line use of Ibance + ET, they were evaluated within 50 days (from 27days
to 50days).
Based on the early response time observed in real-world data mentioned above, it is proposed
a prospective study to further observe the tumor reduction rate in real-world, including to
identify the time of patient symptom improvement according to the quality of life scale.