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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Advanced Breast Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico A. Gemelli - IRCCS

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Through study completion, an average of 1 year".

Secondary Outcomes

Objective response rate (ORR)

ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).

Time frame: Through study completion, an average of 1 year".

Overall survival (OS)

OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).

Time frame: Through study completion, an average of 1 year".

Incidence of Adverse Events (AEs)

AEs related to the treatment and evaluated according to CTCAE v5.0

Time frame: Through study completion, an average of 1 year".

Central Contacts

Alessandra Fabi, MD

CONTACT

0039 0630157337 alessandra.fabi@policlinicogemelli.it

Data from ClinicalTrials.gov

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