Evaluating hormone receptors and HER2 levels in advanced 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06243432
This study is trying to see how hormone receptor status and HER2 levels affect treatment responses in patients with advanced breast cancer who have been treated with a specific combination of therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06243432 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between hormone receptor status and HER2 expression levels in patients with advanced breast cancer who have been treated with a first-line CDK4/6 inhibitor combined with endocrine therapy. It is a retrospective multicentric analysis conducted in Italy, focusing on patients diagnosed with HR+/HER2- advanced breast cancer. The study will analyze treatment responses based on immunohistochemical evaluations of hormone receptors and HER2 levels.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with HR+/HER2- advanced breast cancer who have received specific first-line treatments.
Not a fit: Patients with HER2 positive or triple negative breast cancer, or those who have previously undergone chemotherapy for metastatic disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor more effective treatment strategies for patients with advanced breast cancer.
How similar studies have performed: While this study focuses on a specific patient population, similar observational studies have shown promise in understanding treatment responses based on hormone receptor and HER2 status.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome
- Fondazione Policlinico A. Gemelli - IRCCS — Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Alessandra Fabi, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Alessandra Fabi, MD
- Email: alessandra.fabi@policlinicogemelli.it
- Phone: 0039 0630157337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Breast Carcinoma