To hear about similar clinical trials, please enter your email below
Trial Title:
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer
NCT ID:
NCT06243432
Condition:
Advanced Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
HR+/HER2- advanced breast cancer patients
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico A. Gemelli - IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandra Fabi
Phone:
+390630157337
Email:
alessandra.fabi@policlinicogemelli.it
Contact backup:
Last name:
Alessandra Fabi
Phone:
+390630156124
Email:
alessandra.fabi@policlinicogemelli.it
Start date:
February 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06243432
