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

Recruiting

• Conditions: Breast Neoplasms

• Registration Number: NCT02819882
• Lead Sponsor: Spanish Breast Cancer Research Group

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Study Start: 2016-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1867

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with the different breast cancer subtypes and real distribution of them.	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 Outcome Measures

Name	Time	Method
Differences in the development disease in the group of male vs female patients.	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.
Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis	8 years	Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
Number of participants with specific biomarkers on tumor and blood samples.	8 years	to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.
Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.	8 years	It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk.

Trial Locations

Locations (40)

Hospital General de Elche; 🇪🇸 Elche, Alicante, Spain

Althaia-Xarxa Assistencial de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitario Donostia; 🇪🇸 San Sebastián, Donostia, Spain

Hospital Dr. Negrín; 🇪🇸 Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain

Hospital Infanta Sofía; 🇪🇸 San Sebastián de los Reyes, Madrid, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Mallorca, Spain

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