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due to low accrual rate
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| Name | Class |
|---|---|
| Borstkanker Onderzoek Groep | NETWORK |
| Comprehensive Cancer Centre The Netherlands | OTHER |
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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.
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.
In the Netherlands approximately one out of eight women will be diagnosed with breast cancer; 5% have metastatic disease at presentation. Because metastatic breast cancer is considered to be an incurable disease, it is only treated with a palliative intent. Recent retrospective studies have demonstrated that (complete) resection of the primary tumor significantly improves the outcome of patients with primary metastatic breast cancer. However, other studies showed that the survival benefit in patients who underwent surgery is caused by selection bias.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront surgery | Experimental | Upfront surgery followed by systemic treatment |
|
| Systemic therapy | Other | Systemic therapy possibly followed by local treatment of the breast tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| upfront breast surgery | Procedure | surgery of primary tumor, lumpectomy or mastectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival is defined in months from the time of randomization until death. Overall survival will be expressed as the median survival in months. | participants will be followed until death (expected median survival 31 months for surgery group) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | The EORTC QLQ - C30 and BR23 questionnaires will be used for the measurement of the quality of life. The quality of life will be assessed at 3, 6, 12, 18 months and 2,3,4,5 years after randomisation | 5 years after randomisation |
| Two year survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M.F. Ernst, dr | Jeroen Bosch Ziekenhuis | Principal Investigator |
| A.C. Voogd, dr | Maastricht University Medical Centre | Principal Investigator |
| V.C.G. Tjan-Heijnen, Prof, dr | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands | ||||
| Medisch Centrum Alkmaar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22469291 | Derived | 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. |
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| systemic therapy |
| Other |
chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast) |
|
The percentage of patients who survive two years after randomization will be determined. |
| 2 yrs after randomisation |
| Number of unplanned local therapies | The number of patients who will receive local treatment at another point than scheduled | 5-6 months after randomisation |
| Difference in systemic therapy given | register which patients receive what treatments | 6 months after randomisation |
| Determination of pathological resection margin | The definition of a complete resection in this trial means free resection margins for the invasive component. | Pathological report approximately 1 day after surgery |
| Number of treatments of the axillary lymph nodes | register which patients receive these treatments | 6 months after randomisation |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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