Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)

4. marts 2020 opdateret af: BELEN RUIZ-ANTORAN

Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

220

Kontakter og lokationer

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

Studiesteder

  • Spanien
      • Madrid, Spanien, 28222
        • Puerta de Hierro University Hospital

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 til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.

Beskrivelse

Inclusion Criteria:

  • Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
  • Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.

Exclusion Criteria:

  • Given the characteristics of the study there are no exclusion criteria.

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
Pertuzumab
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
Trastuzumab emtansine
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival.
Tidsramme: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression free survival.
Tidsramme: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
Best overall response rate
Tidsramme: Through study completion, an average of 4 year
Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
Through study completion, an average of 4 year
Duration of response (DOR)
Tidsramme: Through study completion, an average of 4 year
The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
Through study completion, an average of 4 year
Time to treatment failure
Tidsramme: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Time to Objective Response
Tidsramme: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
Time to change treatment
Tidsramme: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Time to next treatment
Tidsramme: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
All suspected Grade 3/4/5 adverse reactions
Tidsramme: Through study completion, an average of 4 year
Through study completion, an average of 4 year
Adverse events of special interest to anti HER2 Mab (AESI)
Tidsramme: Through study completion, an average of 4 year
  • AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration)
  • AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease
Through study completion, an average of 4 year
AEs of scientific interest
Tidsramme: Through study completion, an average of 4 year
  • An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab)
  • Other AEs leading to treatment discontinuation
Through study completion, an average of 4 year

Samarbejdspartnere og efterforskere

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

Sponsor

BELEN RUIZ-ANTORAN

Efterforskere

  • Ledende efterforsker: Belén Ruiz-Antorán, PhD, Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain

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)

1. december 2017

Primær færdiggørelse (Faktiske)

1. oktober 2018

Studieafslutning (Faktiske)

31. januar 2020

Datoer for studieregistrering

Først indsendt

11. januar 2017

Først indsendt, der opfyldte QC-kriterier

16. januar 2017

Først opslået (Skøn)

19. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML29844

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 Brystneoplasmer

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner