Intervention to Hepatic and Pulmonary Metastasis in Breast Cancer Patients

NCT02251353 | Unknown DMC

• 1 other identifier: IMET
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Metastasis

Keywords

breast cancer, intervention to metastasis

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Time interval between diagnosis and death

  3 years

Secondary Outcomes (2)

• Progression free survival (PFS)

  3 years

• Morbidity due to treatment modality

  6 months

Study Arms (1)

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; Drug: systemic treatment

Interventions

intervention PROCEDURE

hepatic and/or pulmonary resection, radiofrequency ablation (RFA), transcatheter arterial chemoembolization, CyberKnife stereotactic radiosurgery

Also known as: Surgery, Chemotherapy,stereotactic radiosurgery

lung and/or hepatic metastasis

systemic treatment DRUG

Systemic therapy

Also known as: no intervention

lung and/or hepatic metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federation of Breast Diseases Societies: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Methods; Surgical Procedures, Operative; Drug Therapy; Radiosurgery; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Therapeutics; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Combined Modality Therapy

Study Officials

• Lutfi Dogan, MD

  Ankara Oncology Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Beyza Ozcinar, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Hasan Karanlik, MD

  Istanbul University Institute of Oncology Capa Istanbul

  STUDY CHAIR

• Atilla Soran

  University of Pittsburgh

  STUDY DIRECTOR

• Serdar Ozbas, MD

  Ankara Guven Hospital

  STUDY CHAIR

Central Study Contacts

Lutfi Dogan, MD

CONTACT

+905057134549; lutfidogan1@yahoo.com

Beyza Ozcinar, MD

CONTACT

drbeyza@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2022
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)