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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06243432

Acronym

CYCLHER

Enrollment

600

Registered

2024-02-06

Start date

2023-02-01

Completion date

2025-03-01

Last updated

2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Carcinoma

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Progression free survival (PFS)	Through study completion, an average of 1 year.	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).

Secondary

Measure	Time frame	Description
Objective response rate (ORR)	Through study completion, an average of 1 year.	ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
Overall survival (OS)	Through study completion, an average of 1 year.	OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
Incidence of Adverse Events (AEs)	Through study completion, an average of 1 year.	AEs related to the treatment and evaluated according to CTCAE v5.0

Countries

Italy

Contacts

Primary ContactAlessandra Fabi, MD

alessandra.fabi@policlinicogemelli.it0039 0630157337

Outcome results