To everyone living with breast cancer and to families, nurses, doctors, and site teams… we’re thinking of you. This month is not about big words, it’s about care.
Five practical, CDISC-aligned choices that protect participants and improve data:
- Separate and link lesions clearly
Use distinct CRFs for Target, Non-Target, and New Lesions with stable lesion IDs. Link TU and TR records via TULNKID/TRLNKID so traceability into SDTM/ADaM is crystal-clear and queries are minimized. - Right-size your imaging capture
Often, it’s enough to record imaging method and date (–METHOD, –DTC in findings domains). Use PR only when procedural detail is truly needed, this keeps forms lean and reduces site errors. - Use the correct non-target terminology
For RECIST 1.1, prefer NON-CR/NON-PD (not “Stable Disease”) for non-target lesions. Apply this consistently in RS and ADRS to avoid misclassification of response. - Treat new lesions with extra care
Capture new lesions on a dedicated form and map them into TU/TR. This supports transparent PD and BOR derivations and avoids rework during analysis. - Plan for heart safety
In advanced breast cancer, plan ahead to monitor cumulative cardiotoxicity (e.g., anthracyclines, anti-HER2 agents). Capture prior therapies, LVEF/echo timing, and consistent units, so risks are visible early and clearly.
If this month feels heavy, we see you. If you’re supporting someone, thank you. If you’re planning a breast-oncology study and want a quick CDISC cross-check of CRFs/specs/derivations or our short BOR & RECIST mapping checklist, we’re happy to help.