Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer

Advanced Breast Carcinoma Clinical Trial

— CYCLHER  

Official title:

Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243432
• Other study ID #: 5519
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: October 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Alessandra Fabi, MD
• Phone: 0039 0630157337
• Email: alessandra.fabi[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 yo
• Histological diagnosis of HR+/HER2- advanced breast cancer
• Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
• Immunohistochemical expression levels of estrogen and progesterone receptors
• First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
• Signing of informed consent approved by local Ethic Committee

Exclusion Criteria:

• Absence of clinical and pathological data that would compromise the definition of the study endpoints
• HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
• Previous chemotherapy for treatment of metastatic disease

Related Conditions & MeSH terms

• Advanced Breast Carcinoma
• Breast Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione Policlinico A. Gemelli - IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).	Through study completion, an average of 1 year".
Secondary	Objective response rate (ORR)	ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).	Through study completion, an average of 1 year".
Secondary	Overall survival (OS)	OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).	Through study completion, an average of 1 year".
Secondary	Incidence of Adverse Events (AEs)	AEs related to the treatment and evaluated according to CTCAE v5.0	Through study completion, an average of 1 year".