Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- Through study completion, an average of 1 year".
- description
- 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 outcomes (3)
- measure
- Objective response rate (ORR)
- timeFrame
- Through study completion, an average of 1 year".
- description
- ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
- measure
- Overall survival (OS)
- timeFrame
- Through study completion, an average of 1 year".
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available