NCT04992156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

August 1, 2021

Last Update Submit

May 18, 2022

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Through study completion, an expected average of 12 months

Study Arms (1)

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

Interventions

PalbociclibDRUG

Palbociclib 125mg/d

Patients cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

You may qualify if:

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

You may not qualify if:

  • Incomplete medical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

  • Liu C, Hu S, Xu X, Zhang Y, Wang B, Song S, Yang Z. Evaluation of tumour heterogeneity by 18F-fluoroestradiol PET as a predictive measure in breast cancer patients receiving palbociclib combined with endocrine treatment. Breast Cancer Res. 2022 Aug 26;24(1):57. doi: 10.1186/s13058-022-01555-7.

    PMID: 36028895DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Dr

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 5, 2021

Study Start

March 15, 2017

Primary Completion

March 15, 2022

Study Completion

April 15, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

CN(1)