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Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer

NCT01392586 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-02-04

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Borstkanker Onderzoek Groep

    collaborator NETWORK

  • Comprehensive Cancer Centre The Netherlands

    collaborator OTHER

  • Jeroen Bosch Ziekenhuis

    lead OTHER

Principal Investigators

  • M.F. Ernst, dr · Jeroen Bosch Ziekenhuis

  • A.C. Voogd, dr · Maastricht University Medical Centre

  • V.C.G. Tjan-Heijnen, Prof, dr · Maastricht University Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01392586 on ClinicalTrials.gov