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

Celgene

Status: Completed

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT02403869

CEL-CMM-2013-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

149 participants in 1 patient group

Group 1

Description:

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