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

29. juni 2022 opdateret af: Celgene

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

149

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Definitive deterioration at 6 months
Tidsramme: 6 months
Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC
6 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Celgene

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. marts 2014

Primær færdiggørelse (Faktiske)

31. januar 2019

Studieafslutning (Faktiske)

31. januar 2019

Datoer for studieregistrering

Først indsendt

19. marts 2015

Først indsendt, der opfyldte QC-kriterier

26. marts 2015

Først opslået (Skøn)

31. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEL-CMM-2013-01

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