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Spots Global Cancer Trial Database for Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy

Official Title: Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy

Study ID: NCT02403869

Interventions

Study Description

Brief Summary: Post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.

Detailed Description: Post-authorization, prospective, multi-centre study in Metastatic Breast Cancer patients treated with second-line monochemotherapy. A total of 200 patients are expected to be recruited from 32 Spanish sites. In this study the results perceived by patients will be compiled to assess overall Quality of Life (QoL) in MBC patients treated with second-line monochemotherapy, using the EORTC QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and its modules EORTC QLQ-BR23 (EORTC Breast Cancer specific) and EORTC QLQ-CIPN20 (EORTC Chemotherapy-Induced Peripheral Neuropathy). Patients will be evaluated at the time of acceptance to participate in the study after signing the informed consent and will be tracked every three months during treatment with second-line monochemotherapy, coinciding with routine assessments within normal clinical practice. When the patient completes treatment with second-line chemotherapy he/she will enter the post-treatment period, with follow-up at six and 12 months after completion of treatment. Also, patients will be followed to assess survival until the end of the study (30 months after enrolment of the last patient in the study). Follow-up time has been established based on the median survival of patients with MBC

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Juan Ramón Jiménez, Huelva, Andalucía, Spain

Hospital Virgen de Valme, Sevilla, Andalucía, Spain

Hospital Virgen del Rocío, Sevilla, Andalucía, Spain

Hospital Miguel Servet, Zaragoza, Aragón, Spain

Hospital Universitario Lozano Blesa, Zaragoza, Aragón, Spain

Hospital Son Llatzer, Palma de Mallorca, Baleares, Spain

Hospital Universitario Son Espases, Palma Mallorca, Baleares, Spain

Hospital Universitario Canarias, La Laguna, Santa Cruz De Tenerife, Canarias, Spain

Hospital Virgen de la Salud. Toledo, Toledo, Castilla La Mancha, Spain

Hospital Universitario Burgos, Burgos, Castilla Y León, Spain

Complejo Hospitalario de León, León, Castilla Y León, Spain

Hospital Bierzo, León, Castilla Y León, Spain

Hospital Universitario Salamanca, Salamanca, Castilla Y León, Spain

Centro Médico Teknon, Barcelona, Cataluña, Spain

Hospital Clinic Barcelona, Barcelona, Cataluña, Spain

Hospital Universitario San Joan de Reus, Reus, Tarragona, Cataluña, Spain

Corporación Sanitaria Parc Taulí- Sabadell, Sabadell, Cataluña, Spain

Hospital Universitario Elche, Elche, Comunidad Valenciana, Spain

Hospital Universitario y Politécnico La Fe, Valencia, Comunidad Valenciana, Spain

H. Infanta Cristina de Badajoz, Badajoz, Extremadura, Spain

H. San Pedro de Alcántara, Cáceres, Extremadura, Spain

Complejo Hospitalario de Ourense, Ourense, Galicia, Spain

Complejo Hospitalario de Pontevedra-Montecelo, Pontevedra, Galicia, Spain

Complejo Hospitalario Universitario de Santiago Compostela, Santiago de Compostela, Galicia, Spain

Complejo Hospitalario de Vigo, Vigo, Galicia, Spain

Hospital Universitario de Navarra, Pamplona, Navarra, Spain

Hospital Universitario Gregorio Marañón, Madrid, , Spain

Hospital Universitario Ramón y Cajal, Madrid, , Spain

Hospital Infanta Sofía, Madrid, , Spain

Contact Details

Name: Bristol-Myers Squibb

Affiliation: Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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