A Study to Determine Biopsy Rate in Participants With a First Relapse of Breast Cancer

January 30, 2017 updated by: Hoffmann-La Roche
This is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. The duration of the study will be approximately 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

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

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Cemic; Oncologia Clinica
      • Moron, Argentina
        • Hospital de Morón
      • Rosario, Argentina
        • CENICLAR
      • San Miguel de Tucuman, Argentina, T4000IAK
        • Centro Médico San Roque

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

Female

Sampling Method

Non-Probability Sample

Study Population

Participants with a first relapse of breast cancer after being treated for eBC.

Description

Inclusion Criteria:

  • Participants with histologically confirmed breast cancer treated for early breast cancer (eBC) with first metastatic relapse disease in the period from January 1, 2014 and December 31, 2015

Exclusion Criteria:

Not Applicable

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
Intervention / Treatment
eBC treated participants
Participants with metastatic disease after previously being treated for eBC were observed for 24 months.
Other: eBC treated participants
No intervention administered in this retrospective observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of biopsied participants with metastatic relapse
Time Frame: Approximately up to 24 months
Approximately up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasis
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC according to each biopsy method
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC with same and different molecular profiles between primary tumor and metastasis for each molecular profile
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Time to relapse
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of participants with type of first line therapy selected for metastatic disease
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of participants influenced with biopsy in mBC
Time Frame: Approximately up to 24 months
Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each systemic treatment scheme in the adjuvant and in the metastatic setting
Time Frame: Approximately up to 24 months
Approximately up to 24 months

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML30038

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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