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


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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)
Administrator Researchweb Support - 2019-12-07 23:05
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