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Completed

NCT Number: NCT03087409

High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up

Collection of follow-up data from the original trial patient cohort.

Completed

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Academic Medical Center, Amsterdam, Netherlands

Loading trial locations.

About this study

Collection of follow-up data from the original trial patient cohort by means of structured patient file abstraction, a questionnaire to the general practitioner, and registry consultations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Enrolment in the original trial.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 2 years

    Overall survival according to the definition and analysis plan of the original study

  2. Relapse-free survival

    Time frame: 2 years

    Relapse-free survival according to the definition and analysis plan of the original study

Secondary outcomes

  1. Incidence of cardiovascular events

    Time frame: 2 years

  2. Incidence of malignancies

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up of a Randomized Phase III Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2017
Registry last updated
May 3, 2024

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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