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

May 14, 2023 updated by: Jinsong Lu, RenJi Hospital

Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hormone receptor-positive breast cancer patients who have received or plan to receive CDK4/6 inhibitors for advanced disease.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.
Drug: CDK4/6 inhibitor
CDK4/6 inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.
From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause.
From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
Adverse events
Time Frame: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)
Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.
From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Anticipated)

April 30, 2026

Study Completion (Anticipated)

December 30, 2028

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-097-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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