Clinical trial · Interventional
Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer
Systemic Therapy With or Without Up Front Surgery of the Primary Tumor in Breast Cancer Patients With Distant Metastases at Initial presenTation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to low accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| systemic therapy | Other | — | UNRESOLVED |
| upfront breast surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Upfront surgery
- description
- Upfront surgery followed by systemic treatment
- interventionNames
- Procedure: upfront breast surgery
- type
- OTHER
- label
- Systemic therapy
- description
- Systemic therapy possibly followed by local treatment of the breast tumor
- interventionNames
- Other: systemic therapy
Primary outcomes (1)
- measure
- Survival
- timeFrame
- participants will be followed until death (expected median survival 31 months for surgery group)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRuiterkamp 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 22469291