Clinical trial NCT02819882: A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Official title: A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Keywords: Unresectable
locally
advanced
metastatic disease
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Novartis
name: AstraZeneca
name: Pfizer
name: Celgene
First posted: 2016-06-30
Enrollment: 1867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with the different breast cancer subtypes and real distribution of them.
timeFrame: 8 years
Secondary outcomes:
measure: Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.
timeFrame: 8 years
measure: Differences in the development disease in the group of male vs female patients.
timeFrame: 8 years
measure: Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
timeFrame: 8 years
measure: Number of participants with specific biomarkers on tumor and blood samples.
timeFrame: 8 years
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General de Elche
state: Alicante
city: Manresa
country: Spain
facility: Althaia-Xarxa Assistencial de Manresa
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Donostia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
state: Gran Canaria
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Infanta Sofía
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Mallorca
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: ICO L´Hospitalet
city: Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Moisés Broggi_institut Catalá D´Oncologia
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario de Málaga
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: IVO-Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hosital General de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Ávila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital de Donostia, San Sebastián, Spain
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Gregorio Marañón, Madrid, Spain
name: Study Director
role: STUDY_DIRECTOR
affiliation: Instituto Valenciano de Oncología (IVO), Valencia, Spain
name: Study Director
role: STUDY_DIRECTOR
affiliation: Complejo Hospital Universitario A Coruña (CHUAC), Galicia, Spain
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain
name: Study Director
role: STUDY_DIRECTOR
References: