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 |
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| Monitoring | n.a. | |||
| Local datamanagement | IKNL | |||
| Funding |
 Funding by KWF |
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| 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):
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