Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Palbociclib

• Registration Number: NCT04992156
• Lead Sponsor: Fudan University

Brief Summary

To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-01
• Study First Posted: 2021-08-05
• Primary Completion: 2022-03-15
• Study Completion: 2022-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Female patients aged 18-70 years.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry.
4. HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization.
5. Palbociclib treatment of metastatic breast cancer for at least one cycle.
6. Available medical history.

Exclusion Criteria

1.Incomplete medical history.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients cohort	Palbociclib	Patients with MBC in the Fudan University Shanghai Cancer Center who underwent whole-body 18F-FES PET/CT before the initiation of Palbociclib was included.

Primary Outcome Measures

Name	Time	Method
PFS	Through study completion, an expected average of 12 months

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China