Metastatic Breast Cancer
Conditions
Keywords
survival, systemic therapy, upfront surgery
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.
Detailed 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.
Interventions
PROCEDUREupfront breast surgery
surgery of primary tumor, lumpectomy or mastectomy
OTHERsystemic therapy
chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast)
Sponsors
Borstkanker Onderzoek Groep
Comprehensive Cancer Centre The Netherlands
Jeroen Bosch Ziekenhuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | participants will be followed until death (expected median survival 31 months for surgery group) | Survival is defined in months from the time of randomization until death. Overall survival will be expressed as the median survival in months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Two year survival | 2 yrs after randomisation | The percentage of patients who survive two years after randomization will be determined. |
| Number of unplanned local therapies | 5-6 months after randomisation | The number of patients who will receive local treatment at another point than scheduled |
| Quality of Life | 5 years after randomisation | 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 |
| Determination of pathological resection margin | Pathological report approximately 1 day after surgery | The definition of a complete resection in this trial means free resection margins for the invasive component. |
| Number of treatments of the axillary lymph nodes | 6 months after randomisation | register which patients receive these treatments |
| Difference in systemic therapy given | 6 months after randomisation | register which patients receive what treatments |
Countries
Netherlands
Outcome results
None listed