Arimidex ± Herceptin: A randomized, controlled, open label study to evaluate the efficacy and safety of trastuzumab in combination with the oral atomatase inhibitor anastrozole compared with anastrozole alone as first and second line treatment administered to postmenopausal, hormone receptor positive patients with HER2 overexpressing metastatic breast cancer
Arimidex ± Herceptin: A randomized, controlled, open label study to evaluate the efficacy and safety of trastuzumab in combination with the oral atomatase inhibitor anastrozole compared with anastrozole alone as first and second line treatment administered to postmenopausal, hormone receptor positive patients with HER2 overexpressing metastatic breast cancer
Project number : 246801
Created by: Ylva Storck, 2018-04-09
Last revised by: Ylva Storck, 2018-04-09
Project created in: FoU Region Örebro län

CompletedCompleted

PUL-anmälan

  1. Arimidex ± Herceptin: A randomized, controlled, open label study to evaluate the efficacy and safety of trastuzumab in combination with the oral atomatase inhibitor anastrozole compared with anastrozole alone as first and second line treatment administered to postmenopausal, hormone receptor positive patients with HER2 overexpressing metastatic breast cancer, PUL-anmälan
  2. Arimidex ± Herceptin: A randomized, controlled, open label study to evaluate the efficacy and safety of trastuzumab in combination with the oral atomatase inhibitor anastrozole compared with anastrozole alone as first and second line treatment administered to postmenopausal, hormone receptor positive patients with HER2 overexpressing metastatic breast cancer, Projektbeskrivning

Titel och sammanfattning

Populärvetenskaplig sammanfattning

Studien syftar till att studera om en ny sorts behandling med en antikropp (trastuzumab) ytterligare kan förbättra effekten av mer etablerad behandling, i detta fall hormonbehandling med anastrozole.

Projektspecifik information

Ämnesord

checked Cancer och onkologi


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Studietyp

Prövning av läkemedel

Fas

II

Randomiserad studie

Ja

Diagnoskod för huvuddiagnos

C50-C50 Malign tumör i bröstkörtel

Multicenterstudie

Ja

Protokollnummer på prövningen

BO16216E/H2223g

EPN diarienr

00-418

Biobankstillstånd

Ej aktuellt

Strålskyddstillstånd

Ej aktuellt

Planerat startdatum

2003-02-26

Planerat slutdatum

2004-12-31

Studiens status

Projektet avslutat

Inklusionsstatus

 Planerat antalAntal tillfrågadeScreen-failureAntal randominserade
n=   1

Vetenskaplig sammanfattning

Primary objective: To evaluate the efficacy of the combination of trastuzumab and anastrozole as compared with anastrozole alone. Efficacy will be determined by assessment of the progression free survival (PFS)

Secondary objectives:

To characterize the safety profile

To determine and compare the overall clinical benefit rate (CBF)

To determine and compare the duration of overall survival, response and two year survival in the two treatment arms

Involverade parter

Arbetsplats

information Added workplaces
Landsting - Region Örebro Län - Hälso- och sjukvård - Område opererande och onkologi - Onkologiska kliniken workplace verified by Region Örebro län on 2018-02-27

Sponsor

information Added workplaces
Företag - Läkemedel etc - Roche

Nationell koordinator

information Added workplaces
Landsting - Stockholms läns landsting - Karolinska Universitetssjukhuset - Onkologi Thorax - Onkologiska kliniken

Medarbetare i projektet

Kenneth Villman
Onkologiska Kliniken, Universitetssjukhuset Örebro

Roll i projektet

checked PI (huvudprövare)

Slutrapport

Slutdatum

2004-12-31

Arimidex ± Herceptin: A randomized, controlled, open label study to evaluate the efficacy and safety of trastuzumab in combination with the oral atomatase inhibitor anastrozole compared with anastrozole alone as first and second line treatment administered to postmenopausal, hormone receptor positive patients with HER2 overexpressing metastatic breast cancer, from FoU Region Örebro län
http://www.researchweb.org/is/en/fourol/project/246801