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Observation of Medical Treatments in MBC HER2-negative Patients (AMBRA)

14. juni 2016 opdateret af: Consorzio Oncotech

Evaluation of Medical Treatments in MBC HER2 Negative Patients in Italy - Observational Study

While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors.

Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments, the choice of the treatment for the advanced disease remains highly empirical and may differ significantly among the different cancer centers.

The purpose of this study is the observation of a cohort of patients with metastatic HER2-negative in terms of:

  1. the choice of chemotherapy treatments starting from the first line of treatment;
  2. factors that may influence these choices;
  3. correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ;
  4. clinical outcome (pattern of relapse, time from diagnosis, etc.);
  5. evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.

Studieoversigt

Status

Ukendt

Detaljeret beskrivelse

In particular, the attention will be on those factors, largely discussed in the literature, that predominantly guide the choice among different therapeutic approaches such as:

  • metastatic sites;
  • hormone receptor status;
  • disease-free interval;
  • grading;
  • response to a previous treatment with hormonal therapy or chemotherapy. The primary objective is the description of medical therapeutic strategies for the first, the second and the subsequent lines of chemotherapy in a cohort of patients with HER2-negative metastatic breast cancer and the evaluation of the possible correlation between the choice of treatment, in the adjuvant phase or for the metastatic disease and also for the patients' characteristics (age, menopausal status, comorbidity).

the secondary objectives are:

  • Analyze the "Time to Treatment Change", defined as the interval of time that elapses from the start of chemotherapy to the discontinuation or the occurrence of any other event. This finding is of a particular clinical relevance, since randomized trials using the "Time To Progression" (TTP) as a measure of effectiveness of the treatment in the study, but this time parameter may not correspond to what is observed in clinical practice, where the revaluations of disease are not conducted at preset intervals as is in the case of controlled clinical trials.
  • Evaluate the correlation between the characteristics of the patients and the choice of the type of chemotherapy.
  • Assess the potential correlation between the type of adjuvant therapy and the type of response obtained with the first-line treatment and between the answer to this last therapy line and second/third one.
  • Assess the adherence to the literature's recommendations (Consensus Conferences and Guide-lines) of the choices between the sequential therapy vs the combination therapy in different lines of treatment (first, second, third line) of the metastatic disease.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1500

Kontakter og lokationer

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

Studiekontakt

  • Navn: MD

Undersøgelse Kontakt Backup

Studiesteder

      • Monza, Italien, 20900
        • Rekruttering
        • A.O. San Gerardo
        • Kontakt:
        • Ledende efterforsker:
          • Marina Elena Cazzaniga, MD

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

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Female patients from Italy with metastatic breast cancer.

Beskrivelse

Inclusion Criteria:

  1. Patients with HER2-negative metastatic breast cancer (Stage IV), that have received or not the endocrine therapy for the metastatic disease and that are candidate for the first-line chemotherapy treatment in the years 2014-2015 (prospective cohort), or patients that have received a treatment of first, second or subsequent-line of chemotherapy for the metastatic disease in the years 2012-2013 (retrospective cohort).
  2. Age > 18 years
  3. Availability of all information required by the study, in particular:

    • histology
    • hormone receptor status
    • grading
    • stage of disease at diagnosis
    • type of surgery for the primary tumor
    • type of adjuvant therapy (chemotherapy or hormone therapy)
    • type of medication received as adjuvant therapy
    • date and seat of the relapse
    • type of treatment received for the first / second / third-line of treatment of metastatic disease (chemotherapy or hormone therapy)
    • type of chemotherapy regimen used and details about the medication, date and seat of disease progression
  4. Written informed consent (in case of the impossibility to obtain the consent in writing, eg, death of the patient, the data will be collected as required by the Guarantor, OJ N.72 of March 26, 2012)

Exclusion Criteria:

  1. Patients with metastatic disease at diagnosis
  2. Patients with HER2-positive breast
  3. Participation in clinical research protocols, both for the retrospective cohort and for the perspective one

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
Intervention / Behandling
Prospective
Observation of treatment management of patients with metastatic breast cancer that have been treated or not with hormonal therapy and candidate for a first line chemotherapeutic treatment in the years 2014-2015 will be observed until the end of the study.
Group/cohort
Retrospective
Observation of treatment management of patients with metastatic breast cancer that have been treated with a first, second or following line of chemotherapeutic treatment for metastatic disease in the years 2012-2013.
Group/cohort

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number subsequent lines of treatment.
Tidsramme: Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)
Evaluation of correlation between treatment choice and patient characteristic ( age, menopausal status, comorbidity).
Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Treatment Change
Tidsramme: Outcome 2 assessed up to 24 months (2012 until 2016 where applicable)
evaluation of the time interval between the begin of chemotherapic treatment and its interruption.
Outcome 2 assessed up to 24 months (2012 until 2016 where applicable)
Correlation between the type of adjuvant therapy and the type of response to the treatment
Tidsramme: Outcome 3 assessed up to 24 months (2012 until 2016 where applicable)
Outcome 3 assessed up to 24 months (2012 until 2016 where applicable)
Evaluation of the adherence to the Consensus Conferences and Guidelines concerning the choice between the sequential therapies versus the combination therapies ( first, second, third line)
Tidsramme: Outcome 4 assessed up to 24 months (2012 until 2016 where applicable)
Outcome 4 assessed up to 24 months (2012 until 2016 where applicable)

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Marina Cazzaniga, MD, Azienda Ospedaliera San Gerardo-Oncologia Medica (Saint Gerard Hospital-Medical Oncology)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. maj 2015

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

15. december 2014

Først indsendt, der opfyldte QC-kriterier

18. februar 2015

Først opslået (Skøn)

19. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • GIM13-AMBRA

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metastatisk brystkræft

Kliniske forsøg med Observation of treatment management

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