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NCT04992156 Clinical Trial

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

Metastatic Breast Cancer Clinical Trial

Official title:
A Retrospective Study of Prediction of 18F-FES-PET/CT Parameters on the Outcome of Palbociclib Combined With Endocrine Therapy in Patients With HR+ and HER2-metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04992156
Other study ID # YOUNGBC-15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2017
Est. completion date April 15, 2022

Study information
Verified date May 2022
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date April 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Palbociclib
Palbociclib 125mg/d

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Through study completion, an expected average of 12 months
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