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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761616
• Other study ID #: ML30038
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: January 30, 2017
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• eBC treated participants
No intervention administered in this retrospective observational study.

Locations

Country	Name	City	State
Argentina	Cemic; Oncologia Clinica	Buenos Aires
Argentina	Hospital de Morón	Moron
Argentina	CENICLAR	Rosario
Argentina	Centro Medico San Roque	San Miguel de Tucuman

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of biopsied participants with metastatic relapse		Approximately up to 24 months
Secondary	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
Secondary	Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site		Approximately up to 24 months
Secondary	Percentage of biopsied participants at first relapse mBC according to each biopsy method		Approximately up to 24 months
Secondary	Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor		Approximately up to 24 months
Secondary	Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases		Approximately up to 24 months
Secondary	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
Secondary	Time to relapse		Approximately up to 24 months
Secondary	Percentage of participants with type of first line therapy selected for metastatic disease		Approximately up to 24 months
Secondary	Percentage of participants influenced with biopsy in mBC		Approximately up to 24 months
Secondary	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