Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02819882

A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Elche, Elche, Alicante, Spain

Loading trial locations.

About this study

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time.

The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards.
  • Patients who died are allowed to be included on the study.
  • Able and willing to provide written informed consent if they are alive.
  • Age ≥ 18 years.
  • Availability to medical records access and all data related to the disease management.

Exclusion criteria

None

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Number of patients with the different breast cancer subtypes and real distribution of them.

    Time frame: 8 years

    Number of patients with the different breast cancer subtypes (Luminal A-like, Luminal B-like [HER2 negative], Luminal B-like [HER2 positive], HER2-enriched and Triple Negative) of the unresectable locally advanced or metastatic disease

Secondary outcomes

  1. Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.

    Time frame: 8 years

    It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk.

  2. Differences in the development disease in the group of male vs female patients.

    Time frame: 8 years

    It will be performed an analysis separately for each subtype and by male and female and it will analyse if there are any significative difference between them.

  3. Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis

    Time frame: 8 years

    Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis

  4. Number of participants with specific biomarkers on tumor and blood samples.

    Time frame: 8 years

    to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

MS Study Project Manager

CONTACT

[email protected]

+34 916892870

Start-Up Unit Manager

CONTACT

[email protected]

+34 916892870

Sponsors and collaborators

Lead sponsor

Spanish Breast Cancer Research Group

Other

Collaborators

  • AstraZeneca
  • Celgene
  • Hoffmann-La Roche
  • Novartis
  • Pfizer

Registry information

Acronym: REGISTEM

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2016
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.