Clinical trial NCT03417115: Breast Cancer Registry Platform
Official title: Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Epidemiology
Registry
Health Services Research
Germany
Palliative Treatment
Adjuvant Treatment
Neoadjuvant Treatment
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.

Brief 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.

Detailed description: OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life in patients with breast cancer will be evaluated for up to five years.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment reality
timeFrame: 5 years
Secondary outcomes:
measure: Best Response
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Health-related quality of life (Patient-reported outcome)
timeFrame: 3.5 years
measure: Disease-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Many locations
country: Germany
facility: Multiple sites all over germany
Study officials:
affiliation: Praxis für interdisziplinäre Onkologie & Hämatologie
name: Norbert Marschner, MD
role: STUDY_CHAIR
References:
citation: Thill M, Zahn MO, Welt A, Stickeler E, Nusch A, Fietz T, Rauh J, Wetzel N, Kruggel L, Janicke M, Marschner N, Harbeck N, Wockel A, Decker T; OPAL study group. Treatment and outcome in metastatic lobular breast cancer in the prospective German research platform OPAL. Breast Cancer Res Treat. 2023 Apr;198(3):545-553. doi: 10.1007/s10549-023-06882-7. Epub 2023 Feb 18.