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.
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
Study Type
OBSERVATIONAL
Enrollment
149
Definitive deterioration at 6 months
Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC
Time frame: 6 months
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
Time frame: 3 Months
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
Time frame: 9 Months
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
Time frame: 12 Months
Time to Definitive deterioration (TTDD)
Estimated median TTDD using the actuarial method
Time frame: Up to 42 months
Overall survival
Estimated overall survival using the Kaplan-Meier method
Time frame: Up to 42 months
TTDD as a prognostic factor
Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.
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Hospital Juan Ramón Jiménez
Huelva, Andalusia, Spain
Hospital Virgen de Valme
Seville, Andalusia, Spain
Hospital Virgen del Rocío
Seville, Andalusia, Spain
Hospital Miguel Servet
Zaragoza, Aragon, Spain
Hospital Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Son Espases
Palma Mallorca, Balearic Islands, Spain
Hospital Universitario Canarias
La Laguna, Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario Burgos
Burgos, Castille and León, Spain
Complejo Hospitalario de León
León, Castille and León, Spain
...and 19 more locations
Time frame: Up to 42 months
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
Time frame: Up to 42 months
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.
Time frame: Up to 42 months
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
Time frame: Up to 42 months
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
Time frame: Up to 42 months
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.
Time frame: Up to 42 months