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

NCT02403869 | Completed

• 1 other identifier: CEL-CMM-2013-01
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 29

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.

Conditions

Breast Neoplasms

Keywords

Metastatic breast cancer; Monotherapy; chemotherapy; second line; treatment; Her 2 negative

Outcome Measures

Primary Outcomes (1)

• Definitive deterioration at 6 months

  Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC

  6 months

Secondary Outcomes (11)

• Definitive deterioration at 3 months

  3 Months

• Definitive deterioration at 9 months

  9 Months

• Definitive deterioration at 12 months

  12 Months

• Time to Definitive deterioration (TTDD)

  Up to 42 months

• Overall survival

  Up to 42 months

Study Arms (1)

Group 1

MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MBC patients, older than or equal to 18 years of age, on second line of treatment with chemotherapy regimens in monotherapy and Her-2/neu-negative status

You may qualify if:

• Patients who give their written informed consent.
• Patients with metastatic breast cancer who start treatment with second-line monochemotherapy.
• Patients of both sexes, at least 18 years of age and of any race.
• Patients with life expectancy longer than or equal to 12 weeks.
• Patients with histological or cytological diagnosis of Her-2/neu negative breast adenocarcinoma.
• Patients with ability enough to understand the questionnaires.

You may not qualify if:

• Pregnant or lactating women.
• Patients who have been treated with chemotherapy in the last three weeks
• Patients who refuse to participate in the study.

Sponsors & Collaborators

• Celgene: lead

Study Sites (29)

Hospital Juan Ramón Jiménez

Huelva, Andalusia, 21005, Spain

Location

Hospital Virgen de Valme

Seville, Andalusia, 41013, Spain

Location

Hospital Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital Universitario Son Espases

Palma Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario Canarias

La Laguna, Santa Cruz de Tenerife, Canary Islands, 38320, Spain

Location

Hospital Universitario Burgos

Burgos, Castille and León, 09005, Spain

Location

Complejo Hospitalario de León

León, Castille and León, 24001, Spain

Location

Hospital Bierzo

León, Castille and León, 24404, Spain

Location

Hospital Universitario Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Virgen de la Salud. Toledo

Toledo, Castille-La Mancha, 45071, Spain

Location

Centro Médico Teknon

Barcelona, Catalonia, 08022, Spain

Location

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Universitario San Joan de Reus

Reus, Tarragona, Catalonia, 43204, Spain

Location

Corporación Sanitaria Parc Taulí- Sabadell

Sabadell, Catalonia, 08208, Spain

Location

H. Infanta Cristina de Badajoz

Badajoz, Extremadura, 06080, Spain

Location

H. San Pedro de Alcántara

Cáceres, Extremadura, 10003, Spain

Location

Complejo Hospitalario de Ourense

Ourense, Galicia, 32005, Spain

Location

Complejo Hospitalario de Pontevedra-Montecelo

Pontevedra, Galicia, 36071, Spain

Location

Complejo Hospitalario Universitario de Santiago Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Complejo Hospitalario de Vigo

Vigo, Galicia, 36036, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Elche

Elche, Valencia, 03203, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026:, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Infanta Sofía

Madrid, 28702, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: March 12, 2014
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

ES (29)