Long-term Safety and Efficacy of GBG Study Participants

NCT05739591 | Recruiting

• 1 other identifier: GBG 107
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

The ETERNITY study is an international, multicenter, observational study that aims to follow up patients who have participated in a GBG trial for early breast cancer, even after the study has officially ended, in order to collect long-term data on survival, late or delayed adverse events, in addition to information related to pregnancy, fertility and other parameters impacting quality of life.

Conditions

Breast Cancer

Keywords

Registry; Breast cancer, early; Safety; Efficacy; Long-term follow-up; Long-term survival; German Breast Group

Outcome Measures

Primary Outcomes (6)

• Disease-free survival (DFS)

  Time period between randomization and first event (ipsi- or contralateral (non-) in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast))

  10 years

• Invasive disease-free survival (iDFS)

  Time period between randomization and first event (ipsi- or contralateral invasive in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast))

  10 years

• Distant disease-free survival (DDFS)

  Time period between randomization and diagnosis of any distant recurrence of disease, any second primary invasive cancer (non-breast) or death due to any cause, whichever occurs first

  10 years

• Locoregional recurrence-free survival (LRRFS)

  Time period between randomization and diagnosis of any loco-regional (ipsilateral breast (invasive or DCIS), local/regional lymph nodes) recurrence of disease, any invasive contralateral breast cancer or death due to any cause, whichever occurs first

  10 years

• Overall survival (OS)

  Time period between randomization and death of any cause

  10 years

• Other primary outcome measures

  Other study-specific long-term survival endpoints may be defined in the respective study protocol or statistical analysis plan (SAP)

  10 years

Secondary Outcomes (4)

• Long-term toxicity

  10 years

• Anti-cancer therapies

  10 years

• Pregnancies

  10 years

• Impact of study treatment on Quality of Life (QoL)

  10 years

Other Outcomes (1)

• Explorative translational research endpoints

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who participated and received treatment as part of a GBG clinical trial for early breast cancer.

You may qualify if:

• Participation and treatment in a GBG clinical trial for early breast cancer.
• Prospective registration: Written informed consent according to local regulatory requirements prior to data and biomaterial collection.

You may not qualify if:

• Participation and treatment in a non-GBG clinical trial for early breast cancer.
• Patients with advanced or metastatic breast cancer who have participated and received treatment in a GBG clinical trial.

Sponsors & Collaborators

• GBG Forschungs GmbH: lead

Study Sites (3)

MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Ordensklinikum Linz GmbH - BHS

Linz, 4020, Austria

RECRUITING

LKH Salzburg - PMU

Salzburg, 5020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In case of distant disease recurrence, it is recommended - according to guidelines - to confirm diagnosis by histological examination of the metastatic lesion. By signing the informed consent form, the patient agrees to the transfer of biomaterial to GBG. If a histological examination of a metastasis was performed by standard of care, a formalin-fixed paraffin-embedded (FFPE) tumor tissue block from the metastatic lesion should be provided to GBG. Method of material collection (i.e., diagnostic biopsy or surgery) is not part of the registry. The submitted tumor samples will be used for translational research objectives.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Sibylle Loibl, Prof. Dr.

  GBG Forschungs GmbH

  STUDY CHAIR

Central Study Contacts

Thomas Ballhausen, Dr.

CONTACT

0049610274800; eternity@gbg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 22, 2023
• Study Start: October 12, 2022
• Primary Completion (Estimated): May 19, 2030
• Study Completion (Estimated): May 19, 2030
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

AU (3)