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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Advanced Breast Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06243432

5519

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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