NCT04858997

Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients

An Open-label, Prospective Study of Tumor Response Time of Palbociclib in Combination With AI in Real-world First-line Treatment of Postmenopausal Chinese Patients With ER (+) HER2 (-) Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

According to the early assessment(4 weeks) , this prospective study comprehensively investigate TTR of Palbociclib+ET in the first line treatment for HR+/HER2- MBC patients in China real-world study. Furthermore, evaluate the Early Tumor Shrinkage(ETS) of Palbociclib + ET, and assess Treatment Free Interval (TFI) with TTR and ETS；TFI was analyzed at the following time points: ≤24, \>24, ≤36, \> 36, ≤48, \>48 months. Accroding to the follow-up of QoL questionnaire, understand the clinical symptoms improvements time. Meanwhile, cooperation with radiology department, establish a model for predicting early response by observing the imaging and clinical pathological characteristics of patients with ETS.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib,125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
DRUG	AI	AI, orally once daily (continuously)

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2021-04-26
• Last updated: 2021-07-15

Locations

1 site across 1 country: China