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OMEGA

  • Closed

BOOG 2006-02

General Information

BOOG number

BOOG 2006-02

Nickname

OMEGA

Status

  • Closed
Date: 01/09/2011

Other study number

CKTO 2006-09

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.

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

Contact

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

Email trialbureau@iknl.nl
Tel 020 3462544

Monitoring

No monitoring

Funding

Funding by KWF

Design

Randomization: Arm A: Pegylated liposomal doxorubicin Arm B: Oral capecitabine

Endpoints

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)

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.

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 14/07/2006
Nr:M06-015

EC

METC Noord-Holland
Amendments:
Yes

EudraCT number

2006-002046-10

Trial Register

ISRCTN11114726

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