Study Stopped
due to low accrual rate
Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer
SUBMIT
1 other identifier
interventional
10
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2012
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 4, 2014
February 1, 2014
1.9 years
July 5, 2011
February 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (6)
Quality of Life
5 years after randomisation
Two year survival
2 yrs after randomisation
Number of unplanned local therapies
5-6 months after randomisation
Difference in systemic therapy given
6 months after randomisation
Determination of pathological resection margin
Pathological report approximately 1 day after surgery
- +1 more secondary outcomes
Study Arms (2)
Upfront surgery
EXPERIMENTALUpfront surgery followed by systemic treatment
Systemic therapy
OTHERSystemic therapy possibly followed by local treatment of the breast tumor
Interventions
chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast)
Eligibility Criteria
You may qualify if:
- 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 \> 18 years
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jeroen Bosch Ziekenhuislead
- Borstkanker Onderzoek Groepcollaborator
- Comprehensive Cancer Centre The Netherlandscollaborator
Study Sites (26)
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
Related Publications (1)
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.
PMID: 22469291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.M.F.Ernst
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 12, 2011
Study Start
February 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 4, 2014
Record last verified: 2014-02