RecruitingNCT03417115

Breast Cancer Registry Platform

Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data

Sponsor

iOMEDICO AG

Enrollment

6,150 participants

Start Date

Dec 22, 2017

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria16

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 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
ABC cohort I (prospective):
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
ABC cohort II (retrospective):
Confirmed diagnosis of HR-positive, HER2-negative ABC (stage IV defined as synchrone or metachrone diagnosis of distant metastases at inclusion)
Start of initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first, between September 2021 and December 2025
Inclusion is possible regardless of whether patients are alive or deceased at the time of documentation; for patients alive: written informed consent
Prospective 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
All 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
All cohorts:
Age ≥ 18 years