Evaluation of Medical Treatments in MBC Patients According Biological Subtype and Line of Treatments (BIO-META)

May 5, 2015 updated by: Consorzio Oncotech

Evaluation of Medical Treatments (Chemotherapy, Hormonal Therapy and Biological Therapies) in Metastatic Breast Cancer Patients According to Biologic Subtype and Line of Treatment

Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about 13.000 women die every year for this disease . About 6-7% of breast cancer patients are metastatic at diagnosis , while the majority of patients with stage IV has a previous history of breast cancer that has already been treated. According to various prognostic factors (tumor size, lymph nodes involvement, grading, hormone receptors status, HER-2 status), in the worst-case scenario, more than 30% of node-negative breast cancer patients and more than 70% of node-positive patients relapse2.

The evolution of metastatic breast cancer has changed considerably in the last years with the approval of new drugs. In fact, already in 2003 Giordano et al showed that the prognosis of metastatic breast cancer patients was improved significantly from 1970's to 2000 with a median survival of 15 months in the early 1970's compared with 60 months in the last 1990's.

This significant survival gain was obtained with introduction of new drugs as hormonal, chemotherapeutic and biological agents. The greater availability of drugs has led to an increase in number of lines of treatment receiving by metastatic breast cancer patients. However, there are few published data on actual duration of metastatic breast cancer treatments. Moreover, there is no evidence to support a real impact on survival of treatments beyond the second-third line.

Recently, a retrospective analysis of about 199 metastatic breast cancer patients treated with chemotherapy showed that tumor subtype is associated with the duration and number of lines of chemotherapy (for example HER positive versus "triple-negative" patients) .

Study Overview

Status

Unknown

Conditions

Detailed Description

The primary objectives are to evaluate the duration of metastatic breast cancer treatments (chemotherapy, hormonal therapy and biological therapies) according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative) and to evaluate the number of lines of metastatic breast cancer treatments according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative).

The secondary Objectives are to evaluate overall survival according to duration and to number of lines of metastatic breast cancer treatments and to identify predictive factors of number of lines of treatment as for example age, treatment response, biological subtype, metastatic sites, etc and to identify possible elements of different treatment management between participating sites.

The aim of this retrospective and prospective study is to identify the duration of treatments (chemotherapy, hormonal therapy and biological therapies) according to biological subtype and line of treatment in metastatic breast cancer patients.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Candiolo, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia - I.R.C.C.
      • Como, Italy, 22020
        • Azienda Ospedaliera Ospedale Sant'Anna
      • Cuneo, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
      • Frosinone, Italy, 03100
        • Ospedale 'F. Spaziani'
      • Mantova, Italy, 46100
        • Azienda Ospedaliera Carlo Poma
      • Napoli, Italy, 80131
        • Azienda Ospedaliero Universitaria "Federico II"
      • Napoli, Italy, 80131
        • Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'
      • Reggio Emilia, Italy, 42123
        • IRCCS Arcispedale Santa Maria Nuova
      • Roma, Italy, 00144
        • Istituto Regina Elena per lo studio e la cura dei tumori
      • Roma, Italy
        • Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
      • Sora, Italy, 03039
        • Ospedale 'SS. Trinità'
      • Udine, Italy, 33100
        • A.O.U. Santa Maria della Misericordia di Udine
      • Udine, Italy, 33100
        • Azienda Ospedaliero Universitaria ´S. Maria della Misericordia´

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Italian patient with metastatic breast cancer

Description

Inclusion Criteria:

Retrospective cohort All consecutive metastatic breast cancers patients treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from Feb 2014 retrospectively back until 2000.

Prospective cohort All new consecutive metastatic breast cancers patients will be treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from March 2014 to December 2016.

Exclusion Criteria:

Not consecutive metastatic breast cancer patients grouped for a particular biological type (for example: all HER2 positive patients).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Retrospective cohort
All consecutive metastatic breast cancers patients treated in the participating sites with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from Feb 2014 retrospectively back until 2000.
Prospective cohort
All new consecutive metastatic breast cancers patients will be treated in the participating sites with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from March 2014 to December 2016.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration and number of lines' treatment
Time Frame: Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Retrospectively from 2000 up to 2014; prospectively assested up to 32 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival according duration
Time Frame: Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Overall survival according number of lines
Time Frame: Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Predictive factors of number of lines
Time Frame: Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Treatment management
Time Frame: Retrospectively from 2000 up to 2014; prospectively assested up to 32 months
Retrospectively from 2000 up to 2014; prospectively assested up to 32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Oncotech

Investigators

  • Principal Investigator: Claudia Bighin, MD, IRCCS- Azienda Ospedaliera Universitaria San Martino-IST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (ESTIMATE)

November 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM14-BIOMETA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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