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

Completed

• Conditions: Breast Cancer
• Interventions: Other: eBC treated participants

• Registration Number: NCT02761616
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Study Start: 2016-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

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Exclusion Criteria

Not Applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
eBC treated participants	eBC treated participants	Participants with metastatic disease after previously being treated for eBC were observed for 24 months.

Primary Outcome Measures

Name	Time	Method
Percentage of biopsied participants with metastatic relapse	Approximately up to 24 months

Secondary Outcome Measures

Name	Time	Method
Percentage of biopsied participants at first relapse mBC according to each biopsy method	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	Approximately up to 24 months
Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site	Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases	Approximately up to 24 months
Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasis	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	Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor	Approximately up to 24 months
Time to relapse	Approximately up to 24 months
Percentage of participants with type of first line therapy selected for metastatic disease	Approximately up to 24 months
Percentage of participants influenced with biopsy in mBC	Approximately up to 24 months

Trial Locations

Locations (4)

Cemic; Oncologia Clinica; 🇦🇷 Buenos Aires, Argentina

Hospital de Morón; 🇦🇷 Moron, Argentina

CENICLAR; 🇦🇷 Rosario, Argentina

Centro Medico San Roque; 🇦🇷 San Miguel de Tucuman, Argentina