- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03025711
Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)
Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Madrid, Espanja, 28222
- Puerta de Hierro University Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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
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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
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Overall survival.
Aikaikkuna: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
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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
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Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Progression free survival.
Aikaikkuna: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
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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).
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Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
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Best overall response rate
Aikaikkuna: Through study completion, an average of 4 year
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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
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Through study completion, an average of 4 year
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Duration of response (DOR)
Aikaikkuna: Through study completion, an average of 4 year
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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.
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Through study completion, an average of 4 year
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Time to treatment failure
Aikaikkuna: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
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Time to Objective Response
Aikaikkuna: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
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The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
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Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
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Time to change treatment
Aikaikkuna: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
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Time to next treatment
Aikaikkuna: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
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All suspected Grade 3/4/5 adverse reactions
Aikaikkuna: Through study completion, an average of 4 year
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Through study completion, an average of 4 year
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Adverse events of special interest to anti HER2 Mab (AESI)
Aikaikkuna: Through study completion, an average of 4 year
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Through study completion, an average of 4 year
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AEs of scientific interest
Aikaikkuna: Through study completion, an average of 4 year
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Through study completion, an average of 4 year
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Belén Ruiz-Antorán, PhD, Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ML29844
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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