Studieoverzicht - 2010-05 SUBMIT

Number 2010-05 SUBMIT
Nickname SUBMIT
Status Closed Date: 23-12-2013
Inclusion closed
Other study number(s)
Participating parties/groups
Full title Systemic therapy with or without Up front surgery of the primary tumor in Breast cancer patients with distant Metastases at Initial presenTation
Phase and type Randomized Phase III
Age ≥18
Menopausal status Both pre- and postmenopausal
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
CCMO approval Yes Date: Nr: NL30331.028.11
EudraCT nr. n.a.
Trial Register NCT01392586
METC approval Yes Date: 01-06-2011 METC: METOPP Nr: M407
Amendments Yes Date: 01-05-2012
KWF-CKS approval Yes Date: 15-03-2011 Nr: JBZ 2011-4995
News item
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
Monitoring n.a.
Local datamanagement IKNL
Funding Logo KWF.jpgFunding by KWF


Study design SUBMIT


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


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
Main 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
Documents (public):

Protocol synopsis

Documents (protected):
In order to see this content you need to be logged on.