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

Breast Neoplasms Clinical Trial

— REGISTEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02819882
• Other study ID #: GEICAM 2014-03
• Status: Recruiting
• Start date: August 2016
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Spanish Breast Cancer Research Group
• Contact: MS Study Project Manager
• Phone: +34 916892870
• Email: inicio_ensayos[@]geicam.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1867
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital San Juan de Alicante	Alicante
Spain	Hospital Nuestra Señora de Sonsoles	Ávila
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Moisés Broggi_institut Catalá D´Oncologia	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Germans Trias i Pujol	Barcelona
Spain	ICO L´Hospitalet	Barcelona
Spain	Hospital Universitario de Basurto	Bilbao	Vizcaya
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital General de Elche	Elche	Alicante
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Gran Canaria
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
Spain	Hospital de León	León
Spain	Hospital Lucus Augusti	Lugo
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario de Málaga	Málaga
Spain	Althaia-Xarxa Assistencial de Manresa	Manresa	Barcelona
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Son Llatzer	Palma de Mallorca	Mallorca
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital de Sagunto	Sagunto	Valencia
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Donostia	San Sebastián	Donostia
Spain	Hospital Infanta Sofía	San Sebastián de los Reyes	Madrid
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hosital General de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Spain	IVO-Instituto Valenciano de Oncología	Valencia
Spain	Hospital Clínico Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (6)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	AstraZeneca, Celgene, Hoffmann-La Roche, Novartis, Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with the different breast cancer subtypes and real distribution of them.	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	8 years
Secondary	Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.	It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk.	8 years
Secondary	Differences in the development disease in the group of male vs female patients.	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.	8 years
Secondary	Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis	Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis	8 years
Secondary	Number of participants with specific biomarkers on tumor and blood samples.	to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.	8 years

External Links

•   Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group