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

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT02403869
• Lead Sponsor: Celgene

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

Study Timeline

• Study Start: 2014-03-12
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Definitive deterioration at 6 months	6 months	Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC

Secondary Outcome Measures

Name	Time	Method
Definitive deterioration at 3 months	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
Definitive deterioration at 9 months	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
Definitive deterioration at 12 months	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 to Definitive deterioration (TTDD)	Up to 42 months	Estimated median TTDD using the actuarial method
Overall survival	Up to 42 months	Estimated overall survival using the Kaplan-Meier method
TTDD as a prognostic factor	Up to 42 months	Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.
Quality of life	Up to 42 months	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
Quality of life every 3 months	Up to 42 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.
Chemotherapy-induced peripheral neuropathy	Up to 42 months	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
Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20	Up to 42 months	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
Definitive deterioration	Up to 42 months	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.

Trial Locations

Locations (29)

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Andalucía, Spain

Hospital Virgen de Valme; 🇪🇸 Sevilla, Andalucía, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Andalucía, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Universitario Lozano Blesa; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Baleares, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma Mallorca, Baleares, Spain

Hospital Universitario Canarias; 🇪🇸 La Laguna, Santa Cruz De Tenerife, Canarias, Spain

Hospital Virgen de la Salud. Toledo; 🇪🇸 Toledo, Castilla La Mancha, Spain

Hospital Universitario Burgos; 🇪🇸 Burgos, Castilla Y León, Spain

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