Health TrialsbyHealthPanel

Breast Cancer Registry Platform

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG

About this trial

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female and male patients with early breast cancer (stage I-III defined as breast cancer that has not spread beyond the breast or the axillary lymph nodes)

Patients at the start of their initial systemic treatment for EBC, i.e. at start of neoadjuvant treatment for patients receiving neoadjuvant therapy or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, whatever was given first

Female and male patients with advanced breast cancer (stage IV defined as synchrone or metachrone diagnosis of distant metastases at inclusion)

Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first

Disqualifiers

None

Trial population

Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

6,150 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Advanced breast cancer - Her2 positive
Group B: Advanced breast cancer - triple negative
Group C: Advanced breast cancer - HR positive, Her2 negative
Group D: Early breast cancer - HER2 positive
Group E: Early breast cancer - triple negative
Group F: Early breast cancer - HR positive, HER2 negative

Trial outcomes

Primary outcomes

1

Treatment reality

Description of treatment reality (Course of systemic treatments and sequential treatments) applied in German routine practice measured as the frequency of the various systemic treatments applied per line of therapy.

Time frame
5 years

Secondary outcomes

1

Best Response

Documentation of response rates per line of treatment.

Time frame
5 years
2

Progression-free survival

Documentation of progression-free survival per line of treatment.

Time frame
5 years
3

Overall survival

Documentation of date of death.

Time frame
5 years
4

Health-related quality of life (Patient-reported outcome)

EORTC QLQ-C30 core questionnaire and additional items.

Time frame
3.5 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Multiple sites all over germanyRecruiting Many LocationsGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

iOMEDICO AG

Lead sponsor

Source ClinicalTrials.gov
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