Abstract 187P
Background
The registry platform OPAL started 2017 with the recruitment of patients (pts) with advanced breast cancer. Since May 2021, pts with early breast cancer (EBC, stage I-III) receiving systemic therapy have been recruited. OPAL provides insight into treatment and outcome in routine practice where pts’ sociodemographic and medical characteristics often differ from those treated in clinical trials.
Methods
OPAL is a prospective, observational, open, multicentre clinical registry (NCT03417115). 3000 pts with EBC will be recruited in 3 cohorts: 1500 pts with hormone receptor (HR) positive, HER2-negative, 750 pts with HER2-positive and 750 pts with triple-negative EBC. Over 150 sites (comprehensive cancer centres, clinics, and office-based gynaecologic or medical oncologists) all over Germany are participating. All pts are recruited at start of their first systemic treatment. There is no treatment specification. OPAL EBC collects detailed information on neoadjuvant, post-neoadjuvant, adjuvant and extended adjuvant treatments, patient and tumour characteristics, physician-reported factors potentially influencing treatment decision, biomarker testing and additional treatments (surgery, radiotherapy). Data are collected in electronic case report forms; plausibility checks and data monitoring are performed to ensure data quality. Patient-reported outcomes (PROs) are assessed using the EORTC-QLQ-C30 and -BR23 (every 3 months for 3.5 years). In addition, pts are asked to give informed consent to use their routinely collected tumor samples for future investigational translational research.
Results
By April 2022, a total of 1225 pts had been recruited by over 100 sites. Data cut for the first interim analysis was March 31st, 2022. First results on pts and disease characteristics, biomarker testing, and treatment will be presented.
Conclusions
OPAL will show treatment patterns of pts with EBC in routine care in Germany, implementation of newly approved drugs, effectiveness (e.g. disease-free survival) and PROs in a “real world” setting.
Clinical trial identification
NCT03417115.
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO.
Funding
Roche Pharma AG, Eisai GmbH, Lilly Deutschland GmbH, Mundipharma GmbH, Mylan GmbH, Onkovis GmbH, Pfizer Pharma GmbH, AstraZeneca GmbH, Gilead Sciences GmbH, Daiichi Sankyo Deutschland GmbH.
Disclosure
A. Welt: Financial Interests, Full or part-time Employment: University Hospital Essen; Financial Interests, Advisory Role: Roche, Pfizer, Tesaro, AstraZeneca, Lilly, Eisai, Amgen, Daiichi Sankyo, Interplan; Financial Interests, Advisory Role, and Contracted Research: Novartis. A. Wöckel: Financial Interests, Advisory Role: Amgen, AstraZeneca, Aukarimed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD, Seagen, Exact Sciences. E. Stickeler: Financial Interests, Advisory Role: AstraZeneca, Novartis, Roche, Trinovis. N.W. Marschner: Financial Interests, Ownership Interest: iOMEDICO; Financial Interests, Advisory Role: Novartis; Financial Interests, Advisory Role, Contracted Research: Roche, Celgene, Lilly, Mundipharma, Mylan, Amgen; Financial Interests, Advisory Role, Contracted Resaerch: Pfizer. M. Thill: Financial Interests, Advisory Role: Amgen, AstraZeneca, Biom'Up, Daiichi Sankyo, Eisai, Genomic Health, Lilly, MSD, Norgine, Neodynamics, Novartis, Pfizer, pfm medical, Roche, RTI Surgical, Tesaro, iOMEDICO, Tesaro; Financial Interests, Advisory Board: Celgene; Financial Interests, Invited Speaker: Amgen, AstraZeneca, Calgene, Eisai, Genomic Health, MSD, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, Clovis, Hexal, MCI, Medtronic, Omniamed; Financial Interests, Other, Manuscript fees: Amgen, Celgene; Financial Interests, Other, Trial funding: Genomic Health. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Medscape, Art Tempi, Onkowissen, Gilead, Sanofi, Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Roche, Sandoz-Hexal, Seagen, Aptitude Health, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Founding Editor: BreastCare Journal. T. Decker: Financial Interests, Advisory Role: Novartis, iOMEDICO. All other authors have declared no conflicts of interest.