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

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Locoregionally Recurrent
• Metastatic
• CDK4/6 Inhibitors

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 172 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Study population

Groups and cohorts

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

  Drug: CDK4/6 inhibitor

Interventions

• DrugCDK4/6 inhibitor

  CDK4/6 inhibitors

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.

   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)

Secondary outcomes

1. Overall survival

   Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause.

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

2. Adverse events

   Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.

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

Individual participant data

Plan to share: Undecided