Zoek
Inloggen

SUBMIT

  • Closed

BOOG 2010-05

General Information

BOOG number

BOOG 2010-05

Nickname

SUBMIT

Status

  • Closed
Date: 23/12/2013

Full title

Systemic therapy with or without Up front surgery of the primary tumor in Breast cancer patients with distant Metastases at Initial presenTation

Indication

  • Advanced/Metastatic

Subindication

Any HER2, any HR

Target sample size

516

Actual accrual

8
Date: 06/06/2013

Estimated study completion date

31/01/2017

Contact

Sponsor

Jeroen Bosch Ziekenhuis, Den Bosch

Principal Investigator(s)

M. F. Ernst, A.C. Voogd, V.C.G. Tjan-Heijnen

Study manager

J. Ruiterkamp

Central datamanagement and randomization

IKNL Trial Office Zuid S. van Gastel P.O. Box 9101, 6500 HB Nijmegen zuid.trialbureau@iknl.nl

Monitoring

n.a.

Local datamanagement

IKNL

Funding

Funding by KWF

Objectives

In order to report the objectives of the study, the primary and secondary endpoints are listed and described below.

Endpoints

Primary endpoint:

  • Overall survival

Secondary endpoints:

  • Quality of life
  • 2-year survival
  • Number of unplanned local therapies, i.e. surgery or radiotherapy
  • Number of axillary lymph node dissections or axillary radiotherapy
  • Determination of pathological resection margin (margin status) in patients treated by surgery of the primary tumor
  • Type of chemotherapy, immunotherapy and endocrine therapy and number of regimens of systemic therapy

Eligibility Criteria

Inclusion criteria Newly diagnosed primary distant metastatic breast cancer (M1) Anticipated survival of at least 6 months Histologically proven breast cancer Hormonal and HER2Neu status should be known T1-T3, resectable T4 status, N0-N3 Performance status of the patient should allow surgery / systemic therapy Co-morbidity of the patient should allow surgery / systemic therapy Age ³ 18 years Written informed consent Exclusion criteria Primary invasive breast cancer in medical history Other malignancy within the last 10 years, besides basal cell carcinoma of the skin or early stage cervical cancer Surgical treatment / radiotherapy of this breast tumor before randomization Irresectable T4 breast tumor Synchronous bilateral breast cancer

Regulatory Information

CCMO approval

Yes
Nr: NL30331.028.11

EC approval

Yes
Date: 01/06/2011
Nr:M407

EC

Other
Amendments:
Yes
Date Last Amendment: 01/05/2012

EudraCT number

n.a.

Trial Register

NCT01392586

Downloads

Inloggen