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

Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With 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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms

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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañon
  • Madrid, Spain, 28702
    • Hospital Infanta Sofia
  • Andalucía
    • Huelva, Andalucía, Spain, 21005
      • Hospital Juan Ramón Jimenez
    • Sevilla, Andalucía, Spain, 41013
      • Hospital Virgen del Rocío
    • Sevilla, Andalucía, Spain, 41013
      • Hospital Virgen de Valme
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Hospital Miguel Servet
    • Zaragoza, Aragón, Spain, 50009
      • Hospital Universitario Lozano Blesa
  • Baleares
    • Palma Mallorca, Baleares, Spain, 07120
      • Hospital Universitario Son Espases
    • Palma de Mallorca, Baleares, Spain, 07198
      • Hospital Son Llatzer
  • Canarias
    • La Laguna, Santa Cruz De Tenerife, Canarias, Spain, 38320
      • Hospital Universitario Canarias
  • Castilla La Mancha
    • Toledo, Castilla La Mancha, Spain, 45071
      • Hospital Virgen de la Salud. Toledo
  • Castilla Y León
    • Burgos, Castilla Y León, Spain, 09005
      • Hospital Universitario Burgos
    • León, Castilla Y León, Spain, 24001
      • Complejo Hospitalario de León
    • León, Castilla Y León, Spain, 24404
      • Hospital Bierzo
    • Salamanca, Castilla Y León, Spain, 37007
      • Hospital Universitario Salamanca
  • Cataluña
    • Barcelona, Cataluña, Spain, 08022
      • Centro Médico Teknon
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clinic Barcelona
    • Reus, Tarragona, Cataluña, Spain, 43204
      • Hospital Universitario San Joan de Reus
    • Sabadell, Cataluña, Spain, 08208
      • Corporación Sanitaria Parc Taulí- Sabadell
  • Comunidad Valenciana
    • Elche, Comunidad Valenciana, Spain, 03203
      • Hospital Universitario Elche
    • Valencia, Comunidad Valenciana, Spain, 46026:
      • Hospital Universitario y Politécnico La Fe
  • Extremadura
    • Badajoz, Extremadura, Spain, 06080
      • H. Infanta Cristina de Badajoz
    • Cáceres, Extremadura, Spain, 10003
      • H. San Pedro de Alcántara
  • Galicia
    • Ourense, Galicia, Spain, 32005
      • Complejo Hospitalario de Ourense
    • Pontevedra, Galicia, Spain, 36071
      • Complejo Hospitalario de Pontevedra-Montecelo
    • Santiago de Compostela, Galicia, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago Compostela
    • Vigo, Galicia, Spain, 36036
      • Complejo Hospitalario de Vigo
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Universitario de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MBC patients, older than or equal to 18 years of age, on second line of treatment with chemotherapy regimens in monotherapy and Her-2/neu-negative status

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group 1; MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Time to Definitive deterioration (TTDD)	Estimated median TTDD using the actuarial method	Up to 42 months
Overall survival	Estimated overall survival using the Kaplan-Meier method	Up to 42 months
TTDD as a prognostic factor	Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.	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	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.	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	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	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.	Up to 42 months

Collaborators and Investigators

• Sponsor: Celgene

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2014
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: treatment; chemotherapy; Metastatic breast cancer; Monotherapy; second line; Her 2 negative
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CEL-CMM-2013-01