Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Neoplasms
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 ...
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.
Tracking Information
- NCT #
- NCT04858997
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: Wen-Ming Cao, Ph.D., M.D. Department of Breast Medical Oncology, Zhejiang Cancer Hospital
Get Well Soon