Clinical trial NCT02403869: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Metastatic breast cancer
Monotherapy
chemotherapy
second line
treatment
Her 2 negative
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 149
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: 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

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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Definitive deterioration at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Definitive deterioration at 3 months
timeFrame: 3 Months
measure: Definitive deterioration at 9 months
timeFrame: 9 Months
measure: Definitive deterioration at 12 months
timeFrame: 12 Months
measure: Time to Definitive deterioration (TTDD)
timeFrame: Up to 42 months
measure: Overall survival
timeFrame: Up to 42 months
measure: TTDD as a prognostic factor
timeFrame: Up to 42 months
measure: Quality of life
timeFrame: Up to 42 months
measure: Quality of life every 3 months
timeFrame: Up to 42 months
measure: Chemotherapy-induced peripheral neuropathy
timeFrame: Up to 42 months
measure: Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20
timeFrame: Up to 42 months
measure: Definitive deterioration
timeFrame: Up to 42 months
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen de Valme
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
state: Aragón
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Baleares
city: Palma Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: La Laguna, Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Canarias
state: Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud. Toledo
state: Castilla La Mancha
city: Burgos
country: Spain
facility: Hospital Universitario Burgos
state: Castilla Y León
city: León
country: Spain
facility: Complejo Hospitalario de León
state: Castilla Y León
city: León
country: Spain
facility: Hospital Bierzo
state: Castilla Y León
city: Salamanca
country: Spain
facility: Hospital Universitario Salamanca
state: Castilla Y León
city: Barcelona
country: Spain
facility: Centro Médico Teknon
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
state: Cataluña
city: Reus, Tarragona
country: Spain
facility: Hospital Universitario San Joan de Reus
state: Cataluña
city: Sabadell
country: Spain
facility: Corporación Sanitaria Parc Taulí- Sabadell
state: Cataluña
city: Elche
country: Spain
facility: Hospital Universitario Elche
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
state: Comunidad Valenciana
city: Badajoz
country: Spain
facility: H. Infanta Cristina de Badajoz
state: Extremadura
city: Cáceres
country: Spain
facility: H. San Pedro de Alcántara
state: Extremadura
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
state: Galicia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra-Montecelo
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago Compostela
state: Galicia
city: Vigo
country: Spain
facility: Complejo Hospitalario de Vigo
state: Galicia
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Infanta Sofía
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: