NCT06243432

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 24, 2024

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

January 24, 2024

Last Update Submit

April 23, 2024

Conditions

Advanced Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    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 Outcomes (3)

  • Objective response rate (ORR)

    Through study completion, an average of 1 year".

  • Overall survival (OS)

    Through study completion, an average of 1 year".

  • Incidence of Adverse Events (AEs)

    Through study completion, an average of 1 year".

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HR+/HER2- advanced breast cancer patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico A. Gemelli - IRCCS

Rome, 00168, Italy

RECRUITING

Study Officials

  • Alessandra Fabi, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Fabi, MD

CONTACT

0039 0630157337alessandra.fabi@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 6, 2024

Study Start

February 1, 2023

Primary Completion

December 31, 2024

Study Completion

March 1, 2025

Last Updated

April 24, 2024

Record last verified: 2023-10

Locations

IT(1)