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

• Sponsor: Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04992156
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 61
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Palbociclib

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Mar 15, 2017
• Actual Primary Completion Date: Mar 15, 2022
• Actual Study Completion Date: Apr 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients cohort 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.	Drug: Palbociclib; Palbociclib 125mg/d

Outcome Measures

Primary Outcome Measures

1. PFS [Through study completion, an expected average of 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Biyun Wang, Dr, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biyun Wang, MD, Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT04992156
• Other Study ID Numbers: YOUNGBC-15
• First Posted: Aug 5, 2021
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Palbociclib

Study Results

No Results Posted as of May 19, 2022