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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01392586
Other study ID # BOOG 2010-05
Secondary ID
Status Terminated
Phase Phase 3
First received July 5, 2011
Last updated February 2, 2014
Start date February 2012
Est. completion date January 2014

Study information

Verified date February 2014
Source Jeroen Bosch Ziekenhuis
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 > 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
upfront breast surgery
surgery of primary tumor, lumpectomy or mastectomy
Other:
systemic therapy
chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast)

Locations

Country Name City State
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 Jeroen Bosch Ziekenhuis Den Bosch
Netherlands Haga Ziekenhuis, Loc. Leijweg Den Haag
Netherlands Ziekenhuis Bronovo Den Haag
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 St. Elisabeth Ziekenhuis Tilburg
Netherlands Viecuri Medisch Centrum, loc. St Maartens Gasthuis Venlo
Netherlands Isala Klinieken Zwolle

Sponsors (3)

Lead Sponsor Collaborator
Jeroen Bosch Ziekenhuis Borstkanker Onderzoek Groep, Comprehensive Cancer Centre The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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 No
Secondary Two year survival The percentage of patients who survive two years after randomization will be determined. 2 yrs after randomisation No
Secondary Number of unplanned local therapies The number of patients who will receive local treatment at another point than scheduled 5-6 months after randomisation No
Secondary Difference in systemic therapy given register which patients receive what treatments 6 months after randomisation No
Secondary 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 No
Secondary Number of treatments of the axillary lymph nodes register which patients receive these treatments 6 months after randomisation No
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