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

NCT ID: NCT04992156

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-15

Study Completion Date

2022-04-15

Brief Summary

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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

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Palbociclib

Intervention Type DRUG

Palbociclib 125mg/d

Interventions

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Palbociclib

Palbociclib 125mg/d

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Biyun Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36028895 (View on PubMed)

Other Identifiers

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YOUNGBC-15

Identifier Type: -

Identifier Source: org_study_id

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