Breast Cancer Registry Platform (NCT03417115) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Breast Cancer Registry Platform
Germany5,000 participantsStarted 2017-12-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
EBC cohort:
* 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 thera-py or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, what-ever was given first
ABC cohort:
* Female and male patients with advanced breast cancer (stage IV defined as synchronous or metachronous 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
All cohorts:
* Written informed consent
* Patients participating in the PRO module: signing of informed consent form and completion of baseline questionnaire before start of initial systemic treatment for EBC or systemic first-line treatment for ABC
* Patients not participating in the PRO module: within six weeks after start of initial systemic treatment for EBC or systemic first-line treatment for ABC
* Age ≥ 18 years
Exclusion Criteria:
* Patients with prior systemic therapy (cytotoxic, endocrine, or targeted) for EBC or ABC
* Patients who do not receive any systemic therapy for EBC or ABC