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NCT Number: NCT05795335

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

jinsong Lu, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDK4/6 inhibitor

Drug

CDK4/6 inhibitors

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Lu

CONTACT

[email protected]

86(21)68383364

Ziping Wu, MD

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Apr 3, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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