Long-term Safety and Efficacy of GBG Study Participants
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGBG Forschungs GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients who participated and received treatment as part of a GBG clinical trial for early breast cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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))
Time frame
10 years2
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))
Time frame
10 years3
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
Time frame
10 years4
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
Time frame
10 yearsSecondary outcomes
1
Long-term toxicity
Frequency and severity of long-term toxicity associated with study treatment are graded by the current NCI Common Terminology Criteria for Adverse Events version (NCI-CTCAE) or according to the respective study protocol or statistical analysis plan (SAP)
Time frame
10 years2
Anti-cancer therapies
Anti-cancer therapies including anti-hormonal therapy in hormone receptor positive (HR+) breast cancer after study participation are analyzed descriptively
Time frame
10 years3
Pregnancies
Pregnancies after study participation and their outcome are analyzed descriptively.
Time frame
10 years4
Impact of study treatment on Quality of Life (QoL)
In this registry, two questions on content on quality of life and degree of bother by side-effects are used
Time frame
10 yearsOther outcomes
1
Explorative translational research endpoints
Correlation of explorative biomarkers with survival and toxicity endpoints. Details are defined in the corresponding SAP
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov