CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer

NCT ID: NCT05795335

Last Updated: 2023-05-16

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

RECRUITING

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-30

Study Completion Date

2028-12-30

Brief Summary

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This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.

CDK4/6 inhibitor

Intervention Type DRUG

CDK4/6 inhibitors

Interventions

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CDK4/6 inhibitor

CDK4/6 inhibitors

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged ≥18 and older
* Confirmed diagnosis of hormone receptor-positive breast cancer.
* Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
* ECOG 0-2
* Adequate organ function

Exclusion Criteria

* Subjects disable to swallow pills.
* History of immunodeficiency disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jinsong Lu

Jinsong Lu, Chief of Breast Surgery Department, RenJi Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ziping Wu, MD

Role: CONTACT

86(21)68385569

Qi Lu

Role: CONTACT

86(21)68383364

Facility Contacts

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jinsong Lu, MD

Role: primary

Other Identifiers

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KY2022-097-B

Identifier Type: -

Identifier Source: org_study_id

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