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

April 23, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HR+/HER2- advanced breast cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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).
Through study completion, an average of 1 year".

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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).
Through study completion, an average of 1 year".
Overall survival (OS)
Time Frame: 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).
Through study completion, an average of 1 year".
Incidence of Adverse Events (AEs)
Time Frame: Through study completion, an average of 1 year".
AEs related to the treatment and evaluated according to CTCAE v5.0
Through study completion, an average of 1 year".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Alessandra Fabi, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5519 (Other Identifier: DLF, Insel GRUPPE AG)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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