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

Breast Neoplasms Clinical Trial

— DD-CMM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403869
• Other study ID #: CEL-CMM-2013-01
• Status: Completed
• Start date: March 12, 2014
• Est. completion date: January 31, 2019

Study information

• Verified date: June 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Spain	H. Infanta Cristina de Badajoz	Badajoz	Extremadura
Spain	Centro Médico Teknon	Barcelona	Cataluña
Spain	Hospital Clinic Barcelona	Barcelona	Cataluña
Spain	Hospital Universitario Burgos	Burgos	Castilla Y León
Spain	H. San Pedro de Alcántara	Cáceres	Extremadura
Spain	Hospital Universitario Elche	Elche	Comunidad Valenciana
Spain	Hospital Juan Ramón Jiménez	Huelva	Andalucía
Spain	Hospital Universitario Canarias	La Laguna, Santa Cruz De Tenerife	Canarias
Spain	Complejo Hospitalario de León	León	Castilla Y León
Spain	Hospital Bierzo	León	Castilla Y León
Spain	Hospital Infanta Sofía	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Complejo Hospitalario de Ourense	Ourense	Galicia
Spain	Hospital Son Llatzer	Palma de Mallorca	Baleares
Spain	Hospital Universitario Son Espases	Palma Mallorca	Baleares
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Pontevedra-Montecelo	Pontevedra	Galicia
Spain	Hospital Universitario San Joan de Reus	Reus, Tarragona	Cataluña
Spain	Corporación Sanitaria Parc Taulí- Sabadell	Sabadell	Cataluña
Spain	Hospital Universitario Salamanca	Salamanca	Castilla Y León
Spain	Complejo Hospitalario Universitario de Santiago Compostela	Santiago de Compostela	Galicia
Spain	Hospital Virgen de Valme	Sevilla	Andalucía
Spain	Hospital Virgen del Rocío	Sevilla	Andalucía
Spain	Hospital Virgen de la Salud. Toledo	Toledo	Castilla La Mancha
Spain	Hospital Universitario y Politécnico La Fe	Valencia	Comunidad Valenciana
Spain	Complejo Hospitalario de Vigo	Vigo	Galicia
Spain	Hospital Miguel Servet	Zaragoza	Aragón
Spain	Hospital Universitario Lozano Blesa	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Definitive deterioration at 3 months	Description Proportion of patients with definitive deterioration at 3 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons	3 Months
Secondary	Definitive deterioration at 9 months	Proportion of patients with definitive deterioration at 9 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons	9 Months
Secondary	Definitive deterioration at 12 months	Proportion of patients with definitive deterioration at 12 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons	12 Months
Secondary	Time to Definitive deterioration (TTDD)	Estimated median TTDD using the actuarial method	Up to 42 months
Secondary	Overall survival	Estimated overall survival using the Kaplan-Meier method	Up to 42 months
Secondary	TTDD as a prognostic factor	Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.	Up to 42 months
Secondary	Quality of life	Comparison of the mean score of the scales of the EORTC QLQ-C30, EORTC QLQ-BR23 and between patients =70 years and <70 years at baseline, every 3 months approximately and at the time of disease progression or completion of treatment for other reasons	Up to 42 months
Secondary	Quality of life every 3 months	Score in the scales of the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline, every 3 months approximately and at the time of disease progression or completion of treatment for other reasons.	Up to 42 months
Secondary	Chemotherapy-induced peripheral neuropathy	Incidence, management and duration of chemotherapy-induced peripheral neuropathy at baseline, every 3 months approximately up to disease progression and at 6 and 12 months after completion of second-line chemotherapy	Up to 42 months
Secondary	Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20	Assess the effect of chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20 quality of life questionnaire at baseline, every 3 months approximately up to disease progression or completion of treatment for other reasons and at 6 and 12 months after completion of second-line chemotherapy	Up to 42 months
Secondary	Definitive deterioration	Comparison of the proportion of patients with definitive deterioration at every 3 months approximately up to disease progression or completion of treatment for other reasons in patients with ECOG 0-1 and ECOG 2-3, using the chi-squared test.	Up to 42 months