Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy (HeCOG/CDKi)

Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group

The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with CDKi in patients with HR-positive, HER2-negative advanced breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Stage IV

Detailed Description

Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. The investigators will use data from patients treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Eligible patients will be of 18 years or older, women of any menopausal status with HR-positive/HER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer. Treatment combinations of CDKi with any endocrine therapy will be accepted. Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi. Patient clinical data will be obtained from their medical records. Toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits.

Statistical analysis The primary endpoint of the study will be progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Secondary endpoint will be overall survival (OS), defined as the time from treatment initiation to patient death or last contact. Patients alive will be censored at the date of last contact. Adverse events will be graded based on Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).

• Study Type: Observational
• Enrollment (Actual): 340

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Hellenic Oncology Cooperative Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.

Description

Inclusion Criteria:

• 18 years or older
• Αny menopausal status is allowed
• HR-positive/HER2-negative advanced breast cancer
• Patients treated with CDKi in combination with endocrine therapy for their advanced breast cancer
• Combinations of CDKi with any endocrine therapy are allowed
• More than two months of treatment with a CDKi is mandatory

Exclusion criteria:

• Treatment with CDKi as (neo)adjuvant treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with advanced HR-positive breast cancer; patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity rates	Rates of adverse events from the combination of CDKi and endocrine therapy	Time Frame: through the completion of the study, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was defined as the time from diagnosis until death from any cause or last follow-up	Time Frame: from the date of treatment start until death from any cause or date of last contact whichever occurred first, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Hellenic Cooperative Oncology Group

Publications and helpful links

General Publications

• Fountzilas E, Koliou GA, Vozikis A, Rapti V, Nikolakopoulos A, Boutis A, Christopoulou A, Kontogiorgos I, Karageorgopoulou S, Lalla E, Tryfonopoulos D, Boukovinas I, Rapti C, Nikolaidi A, Karteri S, Moirogiorgou E, Binas I, Mauri D, Aravantinos G, Zagouri F, Saridaki Z, Psyrri A, Bafaloukos D, Koumarianou A, Res E, Linardou H, Mountzios G, Razis E, Fountzilas G, Koumakis G. Real-world clinical outcome and toxicity data and economic aspects in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy: the experience of the Hellenic Cooperative Oncology Group. ESMO Open. 2020 Aug;5(4):e000774. doi: 10.1136/esmoopen-2020-000774.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): January 2, 2021

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; outcome; toxicity; CDK
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CDK-HeCOG-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No