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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02761616
Enrollment
76
Registered
2016-05-04
Start date
2016-06-30
Completion date
2016-11-30
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHEReBC treated participants

No intervention administered in this retrospective observational study.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of biopsied participants with metastatic relapseApproximately up to 24 months

Secondary

MeasureTime frame
Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic siteApproximately up to 24 months
Percentage of biopsied participants at first relapse mBC according to each biopsy methodApproximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumorApproximately up to 24 months
Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastasesApproximately up to 24 months
Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasisApproximately up to 24 months
Time to relapseApproximately up to 24 months
Percentage of participants with type of first line therapy selected for metastatic diseaseApproximately up to 24 months
Percentage of participants influenced with biopsy in mBCApproximately 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 settingApproximately 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 profileApproximately up to 24 months

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026