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Intervention to Hepatic and Pulmonary Metastasis in Breast Cancer Patients (IMET)

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ClinicalTrials.gov Identifier: NCT02251353
Recruitment Status : Recruiting
First Posted : September 29, 2014
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Doc. Dr. Serdar Ozbas, Federation of Breast Diseases Societies

Brief Summary:
The number of intervention performed for metastatic breast cancer has dramatically increased over the past 2 decades. Hepatectomy and pulmonary resection for stage IV colorectal cancer is now considered the standard of care for resectable patients with isolated hepatic and/or pulmonary disease and acceptable performance status. However, the indications for resection / intervention of breast cancer origin metastases are not as clearly defined. The aim of this study to focus on emerging data for the intervention (resection and/or radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic radiosurgery) of breast cancer metastatic disease to the lung and liver, with a focus on indications for resection / intervention.

Condition or disease Intervention/treatment
Breast Cancer Metastasis Procedure: intervention Drug: systemic treatment

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Intervention to Hepatic and Pulmonary Metastasis in Breast Cancer Patients: Prospective, Observational, Multi-institutional Registration Study - IMET
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
lung and/or hepatic metastasis
intervention to metastasis (resection and/or radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic radio surgery) vs no intervention (only systemic treatment)
Procedure: intervention
hepatic and/or pulmonary resection, radiofrequency ablation (RFA), transcatheter arterial chemoembolization, CyberKnife stereotactic radiosurgery
Other Name: Surgery, Chemotherapy,stereotactic radiosurgery

Drug: systemic treatment
Systemic therapy
Other Name: no intervention




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 3 years ]
    Time interval between diagnosis and death


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 3 years ]
    Time interval between diagnosis and first date of progression of disease

  2. Morbidity due to treatment modality [ Time Frame: 6 months ]
    Morbidity due to treatment modality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients: 1) who present primary tumor with lung and/or hepatic metastases; 2) those with residual lung and/or hepatic metastases after systemic therapy; and 3) those with relapsed lung and/or hepatic metastases after curative locoregional therapy.
Criteria

Inclusion Criteria:

Metastatic breast cancer (lung and/or hepatic metastasis) 18 years and older Antineoplastic treatment

Exclusion Criteria:

No lung and/or hepatic metastasis Below 18 years No antineoplastic treatment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251353


Contacts
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Contact: Hasan Karanlik, MD +905324025354 hasankaranlik@yahoo.com
Contact: Serdar Ozbas, MD

Locations
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Turkey
Istanbul University Istanbul Medical Faculty Recruiting
Istanbul, Turkey
Contact: Vahit Ozmen, MD         
Sub-Investigator: Abdullah Igci, MD         
Sub-Investigator: Mahmut Muslumanoglu, MD         
Sub-Investigator: Neslihan Cabioglu, MD         
Sponsors and Collaborators
Federation of Breast Diseases Societies
Investigators
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Principal Investigator: Hasan Karanlik, MD Istanbul University Institute of Oncology Capa Istanbul
Study Chair: Atilla Soran, MD University of Pittsburgh

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Responsible Party: Doc. Dr. Serdar Ozbas, Doc Dr Hasan Karanlik, Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier: NCT02251353     History of Changes
Other Study ID Numbers: IMET
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: September 2014

Keywords provided by Doc. Dr. Serdar Ozbas, Federation of Breast Diseases Societies:
breast cancer, intervention to metastasis

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes