Skip to main content
OpenTrials
Completed

NCT Number: NCT02403869

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Juan Ramón Jiménez, Huelva, Andalusia, Spain

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Definitive deterioration at 6 months

    Time frame: 6 months

    Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC

Secondary outcomes

  1. Definitive deterioration at 3 months

    Time frame: 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

  2. Definitive deterioration at 9 months

    Time frame: 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

  3. Definitive deterioration at 12 months

    Time frame: 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

  4. Time to Definitive deterioration (TTDD)

    Time frame: Up to 42 months

    Estimated median TTDD using the actuarial method

  5. Overall survival

    Time frame: Up to 42 months

    Estimated overall survival using the Kaplan-Meier method

  6. TTDD as a prognostic factor

    Time frame: Up to 42 months

    Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.

  7. Quality of life

    Time frame: 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

  8. Quality of life every 3 months

    Time frame: 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.

  9. Chemotherapy-induced peripheral neuropathy

    Time frame: 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

  10. Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20

    Time frame: 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

  11. Definitive deterioration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Acronym: DD-CMM

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2015
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.