The SBG 2004-1 study. A phase II study continuing into a randomised phase III study. Comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel or dose dense epirubicin + cyclophosphamide followed by docetaxel or docetaxel + doxorubicin + cyclophosphamide in lymph node positive breast cancer patients.
The SBG 2004-1 study. A phase II study continuing into a randomised phase III study. Comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel or dose dense epirubicin + cyclophosphamide followed by docetaxel or docetaxel + doxorubicin + cyclophosphamide in lymph node positive breast cancer patients.
Project number : 245391
Created by: Ylva Storck, 2018-03-15
Last revised by: Ylva Storck, 2018-03-15
Project created in: FoU Region Örebro län

CompletedCompleted
2005-01-21
Rekrytering/datainsamling pågår
2017-12-31
Projektet avslutat

Registeranmälan

  1. The SBG 2004-1 study. A phase II study continuing into a randomised phase III study, PUL-anmälan
  2. The SBG 2004-1 study. A phase II study continuing into a randomised phase III study. Comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel or dose dense epirubicin + cyclophosphamide followed by docetaxel or docetaxel + doxorubicin + cyclophosphamide in lymph node positive breast cancer patients., Projektbeskrivning

Titel och sammanfattning

Populärvetenskaplig sammanfattning

This is an adjuvant, open, prospective and randomised study; initially a feasibility phase II study. The results of the phase II study will be the basis for a randomised phase III study.

Projektspecifik information

Ämnesord

checked Cancer och onkologi


(Only selected options are displayed. Click here to display all options)

Studietyp

Prövning av behandling

Fas

II

Randomiserad studie

Ja

Diagnoskod för huvuddiagnos

C50-C50 Malign tumör i bröstkörtel

Multicenterstudie

Ja

Etikprövningsmyndighetens diarienummer

04-647/1

Biobanksavtal

Finns

Inklusionsstatus

 Planerat antalAntal tillfrågadeScreen-failureAntal randominserade
n= 6 screenade 5 inkluderade

Vetenskaplig sammanfattning

Primary objective: Evaluate safety and feasibility in the three arms

Compare breast cancer recurrence-free survival in the tailored doses arm compared with the fixed doses arm or the concurrent drugs arm

Secondary aims: Evaluate the dose intensity in the three arms

Compare distant disease free survival

Compare event-free survival

Compare overall survival

Involverade parter

Arbetsplats

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Område opererande och onkologi - Onkologiska kliniken workplace verified by Region Örebro län on 2018-06-14

Sponsor

Added workplaces

Regioner - Stockholms läns landsting - Karolinska Universitetssjukhuset - Onkologi Thorax - Onkologiska kliniken

Nationell koordinator

Added workplaces

Regioner - Stockholms läns landsting - Karolinska Universitetssjukhuset - Onkologi Thorax - Onkologiska kliniken

Medarbetare i projektet

Kenneth Villman
Överläkare, Onkologiska Kliniken, Universitetssjukhuset Örebro

Roll i projektet

checked PI (huvudprövare eller ansvarig forskare)

The SBG 2004-1 study. A phase II study continuing into a randomised phase III study. Comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel or dose dense epirubicin + cyclophosphamide followed by docetaxel or docetaxel + doxorubicin + cyclophosphamide in lymph node positive breast cancer patients., from FoU Region Örebro län
http://www.researchweb.org/is/en/fourol/project/245391