Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer (SUBMIT)

This study has been terminated.
(due to low accrual rate)
Sponsor:
Collaborators:
Borstkanker Onderzoek Groep
Comprehensive Cancer Centre The Netherlands
Information provided by (Responsible Party):
M.F. Ernst, dr, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01392586
First received: July 5, 2011
Last updated: February 2, 2014
Last verified: February 2014

July 5, 2011
February 2, 2014
February 2012
January 2014   (final data collection date for primary outcome measure)
Survival [ Time Frame: participants will be followed until death (expected median survival 31 months for surgery group) ] [ Designated as safety issue: No ]
Survival is defined in months from the time of randomization until death. Overall survival will be expressed as the median survival in months.
Same as current
Complete list of historical versions of study NCT01392586 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: 5 years after randomisation ] [ Designated as safety issue: No ]
    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
  • Two year survival [ Time Frame: 2 yrs after randomisation ] [ Designated as safety issue: No ]
    The percentage of patients who survive two years after randomization will be determined.
  • Number of unplanned local therapies [ Time Frame: 5-6 months after randomisation ] [ Designated as safety issue: No ]
    The number of patients who will receive local treatment at another point than scheduled
  • Difference in systemic therapy given [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
    register which patients receive what treatments
  • Determination of pathological resection margin [ Time Frame: Pathological report approximately 1 day after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
    register which patients receive these treatments
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • 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)
  • Experimental: Upfront surgery
    Upfront surgery followed by systemic treatment
    Intervention: Procedure: upfront breast surgery
  • Systemic therapy
    Systemic therapy possibly followed by local treatment of the breast tumor
    Intervention: Other: systemic therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01392586
BOOG 2010-05
Yes
M.F. Ernst, dr, Jeroen Bosch Ziekenhuis
Jeroen Bosch Ziekenhuis
  • Borstkanker Onderzoek Groep
  • Comprehensive Cancer Centre The Netherlands
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
Jeroen Bosch Ziekenhuis
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP