A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
- Conditions
- Breast Neoplasms
- Interventions
- Other: No intervention
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1867
- 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.
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Luminal A-like subtype No intervention Patients that express Estrogen receptor (ER), express Progesterone Receptor (PgR)+ (≥ 20%), don't express HER2 and have Ki-67 'low' (\< 14%). Luminal B-like (HER2 negative) subtype: No intervention Patients that express ER and are either PgR- or low (\< 20%) and/or Ki67 'high' (≥ 14%). Triple Negative (TN) subtype No intervention Patients who are negative for the expression of ER, PgR and HER2. Luminal B-like (HER2 positive) subtype: No intervention Patients that express ER and HER2 irrespective of PgR or Ki67 status. HER2-enriched subtype No intervention Patients that express HER2 and don't express ER or PgR.
- 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
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Universitario Donostia
🇪🇸San Sebastián, Donostia, Spain
Althaia-Xarxa Assistencial de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Dr. Negrín
🇪🇸Las Palmas de Gran Canaria, Gran Canaria, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital San Juan de Alicante
🇪🇸Alicante, Spain
Hospital de León
🇪🇸León, Spain
Hospital Lucus Augusti
🇪🇸Lugo, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Tenerife, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
IVO-Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
ICO L´Hospitalet
🇪🇸Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hosital General de Valencia
🇪🇸Valencia, Spain
Hospital Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Ávila, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Hospital Infanta Sofía
🇪🇸San Sebastián de los Reyes, Madrid, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Moisés Broggi_institut Catalá D´Oncologia
🇪🇸Barcelona, Spain