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 | |||||
Website | http://www.boogstudycenter.nl | ||||
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 |
![]() |
|||
Extra |
Design:
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
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):
Back