Studieoverzicht - 2006-02 OMEGA

Number 2006-02 OMEGA
Nickname OMEGA
Status Closed Date: 01-09-2011
Inclusion closed
Other study number(s) CKTO 2006-09
Participating parties/groups
Full title A randomized, open-label phase III study of first-line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a clinical geriatric assessment.
Phase and type Randomized Phase III
Age ≥ 65
Menopausal status Postmenopausal
Indication Advanced/metastatic
Subindication Any HER2, any HR
Target sample size 154
Actual accrual 78 Date: 01-09-2011
Estimated study completion date 31-12-2011
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2006-002046-10
Trial Register ISRCTN11114726
METC approval Yes Date: 14-07-2006 METC: METC Noord-Holland Nr: M06-015
Amendments Yes Date:
KWF-CKS approval Yes Date: 12-07-2006 Nr: CKTO 2006-09
News item
Sponsor Borstkanker Onderzoek Groep
Principal Investigator(s) C.M.J.C Seynaeve, C.H. Smorenburg, M. Wymenga
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization IKNL locatie Amsterdam, Trialbureau
PO Box 9236
1006 AE Amsterdam
Tel 020 3462544
Fax 020 3462597
Monitoring No monitoring
Local datamanagement
Funding Logo KWF.jpgFunding by KWF


Arm A: Pegylated liposomal doxorubicin
Arm B: Oral capecitabine


Primary endpoints:

  • Progression free survival

Secondary endpoints:

  • Response (CR, PR, SD)
  • Clinical benefit
  • Overall survival
  • The relation of respons and toxicity
  • The value of geriatric assessment (CGA)
Main eligibility criteria:
  • Female >=65 years of age, with proven metastatic breast cancer, eligible for first-line chemotherapy.
  • Evaluable (non-measurable) or measurable disease.  
  • ECOG performance score < 3.
  • Compliant with filling out questionnaires in the Dutch language.
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