Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer

NCT ID: NCT06706557

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-11

Study Completion Date

2030-12-31

Brief Summary

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A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

Detailed Description

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Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)

Conditions

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Advanced Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.
* Participants should be at advanced or metastatic setting prior to treatment.
* Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.
* Patients must be accessible for follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicola Fusco, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Europeo di Oncologia

Locations

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European Institute of Oncology

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola Fusco, MD

Role: CONTACT

00390294372079

francesca lombardi, biologist

Role: CONTACT

00390257489425

Facility Contacts

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Nicola Fusco, MD

Role: primary

00390294372079

Other Identifiers

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IEO 1990

Identifier Type: -

Identifier Source: org_study_id

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