Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer
NCT ID: NCT01392586
Last Updated: 2014-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
10 participants
INTERVENTIONAL
2012-02-29
2014-01-31
Brief Summary
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Randomization will take place immediately after the diagnosis of primary distant metastatic breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS) followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed local treatment of the breast tumor.
The primary endpoint of this trial is the 2-years survival. Quality of life is one of the most important secondary endpoints.
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Detailed Description
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SUBMIT is a clinical trial that intends to answer the question whether up front breast surgery in patients with primary distant metastatic breast cancer will result in an improvement of the 2-year survival compared to the survival achieved with systemic therapy and delayed local treatment or systemic therapy alone.
Patients to submit in this study are patients with primary distant metastatic breast cancer, with no prior treatment of the breast cancer, who are 18 years or older and fit enough to undergo surgery and systemic therapy. Exclusion criteria are: history of breast cancer, other malignancy within the last 10 years, surgical treatment or radiotherapy of this breast tumor before randomization, irresectable T4 tumor or synchronous bilateral breastcancer.
Randomization will take place immediately after the diagnosis of primary distant metastatic breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS) followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed local treatment of the breast tumor.
The primary endpoint of this trial is the 2-years survival. Quality of life is one of the most important secondary endpoints.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Upfront surgery
Upfront surgery followed by systemic treatment
upfront breast surgery
surgery of primary tumor, lumpectomy or mastectomy
Systemic therapy
Systemic therapy possibly followed by local treatment of the breast tumor
systemic therapy
chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast)
Interventions
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upfront breast surgery
surgery of primary tumor, lumpectomy or mastectomy
systemic therapy
chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast)
Eligibility Criteria
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Inclusion Criteria
* 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 \> 18 years
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Borstkanker Onderzoek Groep
NETWORK
Comprehensive Cancer Centre The Netherlands
OTHER
Jeroen Bosch Ziekenhuis
OTHER
Responsible Party
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M.F. Ernst, dr
Dr.M.F.Ernst
Principal Investigators
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M.F. Ernst, dr
Role: PRINCIPAL_INVESTIGATOR
Jeroen Bosch Ziekenhuis
A.C. Voogd, dr
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
V.C.G. Tjan-Heijnen, Prof, dr
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Ziekenhuisgroep Twente
Almelo, , Netherlands
Wilhelmina Ziekenhuis
Assen, , Netherlands
Rode Kruis Ziekenhuis
Beverwijk, , Netherlands
Tergooiziekenhuizen, loc Blaricum
Blaricum, , Netherlands
Reinier de Graaf
Delft, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Atrium Medisch Centrum
Heerlen, , Netherlands
Ziekenhuis Elkerliek, loc Helmond
Helmond, , Netherlands
Ziekenhuisgroep Twente, Loc. SMT
Hengelo, , Netherlands
Spaarne Ziekenhuis
Hoofddorp, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Diaconessenhuis
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
St. Antonius Ziekenhuis, Loc. Nieuwegein
Nieuwegein, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
UMC St. Radboud
Nijmegen, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Orbis Medisch Centrum
Sittard, , Netherlands
Haga Ziekenhuis, Loc. Leijweg
The Hague, , Netherlands
Ziekenhuis Bronovo
The Hague, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
Viecuri Medisch Centrum, loc. St Maartens Gasthuis
Venlo, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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References
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Ruiterkamp J, Voogd AC, Tjan-Heijnen VC, Bosscha K, van der Linden YM, Rutgers EJ, Boven E, van der Sangen MJ, Ernst MF; Dutch Breast Cancer Trialists' Group (BOOG). SUBMIT: Systemic therapy with or without up front surgery of the primary tumor in breast cancer patients with distant metastases at initial presentation. BMC Surg. 2012 Apr 2;12:5. doi: 10.1186/1471-2482-12-5.
Other Identifiers
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BOOG 2010-05
Identifier Type: -
Identifier Source: org_study_id
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