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Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies

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ClinicalTrials.gov Identifier: NCT03390894
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
AECC_Asociación Española contra el Cáncer
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Tracking Information
First Submitted Date December 29, 2017
First Posted Date January 4, 2018
Last Update Posted Date December 10, 2020
Actual Study Start Date January 18, 2018
Estimated Primary Completion Date January 2047   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2017)
  • Event Free Survival (EvFS) in neoadjuvant studies. [ Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. ]
    The EvFS, is defined as the time from the randomization of the patients in the studies of origin, to the date of one of the following events:
    • Disease progression during neoadjuvant treatment.
    • Disease relapse (local, regional or distant) after curative surgery.
    • Second primary tumors
    • Death due to any cause.
  • Disease Free Survival (DFS) in adjuvant studies. [ Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. ]
    DFS is defined as the time from the date of randomization of patients in the studies of origin, to the date of one of the following events:
    • Disease relapse (local, regional or distant) after curative surgery.
    • Second primary tumors
    • Death due to any cause.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 29, 2017)
Overall Survival (OS). [ Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. ]
Overall Survival (OS) defined as the time from the date of study enrolment to the date of death from any cause.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
Official Title Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
Brief Summary

This is a multicenter, cohorts study to collect information from patients diagnosed with early-stage invasive breast cancer who have been previously included in a neoadjuvant or adjuvant clinical trial of the GEICAM group.

Patients will be included in this study from the moment of completion of the follow-up of the studies of origin and will be followed for approximately 30 years

Detailed Description

One consequence of the improvement in survival rates of certain tumors such as breast cancer is the increase in the number of patients available for long-term follow-up in randomized controlled clinical trials. This long follow-up allows an additional long-term evaluation of the efficacy, as well as of the sequelae related to the treatments that may occur beyond the time of the primary analysis.

The target population of the study are all patients who were included in neoadjuvant and adjuvant clinical trials of GEICAM performed by the goup since 1998 in the medical oncology units of the participating sites, ensuring a follow-up of patients of approximately 30 years. This will allow to describe the long-term evolution of the patients with invasive breast cancer in early stages.

The information obtained will be very useful to professionals involved in the diagnosis, treatment and monitoring of breast cancer, hospital managers, patients with this condition and society in general. This study provides data of great interest for the estimation of long-term disease requirements.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with invasive breast cancer (early stages) included in neoadjuvant and adjuvant clinical trials with GEICAM's participation.
Condition Invasive Breast Cancer Early Stages
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 29, 2017)
8000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2048
Estimated Primary Completion Date January 2047   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected.
  • Patients whose death or contact loss has not been previously collected in the databases of the original studies.

Exclusion Criteria:

  • Patient who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Study Project Manager 00346592870 inicio_ensayos@geicam.org
Contact: Start-Up Unit Manager 00346592870 inicio_ensayos@geicam.org
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03390894
Other Study ID Numbers GEICAM/2016-03
2017-002850-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor Spanish Breast Cancer Research Group
Collaborators AECC_Asociación Española contra el Cáncer
Investigators
Study Director: Study Director Complejo Hospitalario de Especialidades Virgen de la Victoria
Study Director: Study Director Hospital General Universitario Gregorio Marañón
PRS Account Spanish Breast Cancer Research Group
Verification Date December 2020