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

NCT05795335 | Recruiting FDA Drug

• 1 other identifier: KY2022-097-B
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Locoregionally Recurrent; Metastatic; CDK4/6 Inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (2)

• Overall survival

  From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years

• Adverse events

  From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)

Study Arms (1)

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

Drug: CDK4/6 inhibitor

Interventions

CDK4/6 inhibitor DRUG

CDK4/6 inhibitors

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects disable to swallow pills.
• History of immunodeficiency disease

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ziping Wu, MD

CONTACT

86(21)68385569; wuziping@renji.com

Qi Lu

CONTACT

86(21)68383364; rjllb3364@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jinsong Lu, Chief of Breast Surgery Department, RenJi Hospital

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: April 30, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

CN (1)