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Evaluating treatments for metastatic breast cancer based on biological subtype

Evaluation of Medical Treatments (Chemotherapy, Hormonal Therapy and Biological Therapies) in Metastatic Breast Cancer Patients According to Biologic Subtype and Line of Treatment

Observational Consorzio Oncotech · NCT02284581

This study is testing how different treatments for metastatic breast cancer work for patients with various subtypes to improve their care and outcomes.

Quick facts

Study typeObservational
Enrollment10000 (estimated)
Ages18 Years and up
SexAll
SponsorConsorzio Oncotech Academic / other
Drugs / interventionschemotherapy
Locations35 sites (Aviano and 34 other locations)
Trial IDNCT02284581 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the duration and number of treatment lines for metastatic breast cancer (MBC) patients, focusing on different biological subtypes such as Luminal A, Luminal B, HER2 positive, and triple-negative. It includes both retrospective and prospective cohorts, analyzing treatment outcomes and overall survival based on various prognostic factors. Additionally, an ancillary study will assess patient-reported outcomes for HR+/HER2- patients receiving CDK4/6 inhibitors. The goal is to improve understanding of treatment management and outcomes in MBC.

Who should consider this trial

Good fit: Ideal candidates include patients with metastatic breast cancer receiving first-line therapy at participating sites.

Not a fit: Patients with non-consecutive metastatic breast cancer grouped by specific biological types may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for metastatic breast cancer patients.

How similar studies have performed: Previous studies have shown improvements in treatment outcomes for metastatic breast cancer, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Retrospective cohort All consecutive metastatic breast cancers patients treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from last contact with patient or death which ever event comes first retrospectively back until 1 st of January 2000

Prospective cohort All new consecutive metastatic breast cancers patients will be treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy)from site activation to June 2023.

For the ancillary study

* Patients eligible for GIM 14 - BIO-META study
* HR+ HER2- patients newly diagnosed for mBC receiving CDk4/6 inhibitors as first-line or second-line treatment
* Written informed consent

Exclusion Criteria:

Not consecutive metastatic breast cancer patients grouped for a particular biological type (for example: all HER2 positive patients).

Where this trial is running

Aviano and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Breast CancerMBCmetastaticbreastobservationaldisease management
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.