Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy

NCT04133207 | Completed

• 1 other identifier: CDK-HeCOG-2019
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Stage IV

Keywords

CDK; Breast cancer; toxicity; outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  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

Study Arms (1)

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Treatment with CDKi as (neo)adjuvant treatment

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Oncology Cooperative Group

Athens, Greece

Location

Related Publications (1)

• 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.

  PMID: 32817060 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from patients with breast cancer

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 21, 2019
• Study Start: January 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: January 2, 2021
• Last Updated: February 12, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)