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Completed

NCT Number: NCT02761616

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cemic; Oncologia Clinica, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eBC treated participants

Other

No intervention administered in this retrospective observational study.

Primary outcomes

  1. Percentage of biopsied participants with metastatic relapse

    Time frame: Approximately up to 24 months

Secondary outcomes

  1. 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

  2. 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

  3. Percentage of biopsied participants at first relapse mBC according to each biopsy method

    Time frame: Approximately up to 24 months

  4. 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

  5. Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases

    Time frame: Approximately up to 24 months

  6. 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

  7. Time to relapse

    Time frame: Approximately up to 24 months

  8. Percentage of participants with type of first line therapy selected for metastatic disease

    Time frame: Approximately up to 24 months

  9. Percentage of participants influenced with biopsy in mBC

    Time frame: Approximately up to 24 months

  10. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 4, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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