Breast cancer trials are defined by subtype, measured by pathology or imaging, and followed for years. Capture structures receptor status for eligibility and stratification, cycles and assessments on one schedule, and long follow-up with participant-reported outcomes.
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Oestrogen receptor
Progesterone receptor
HER2 status
Clinical T stage
Clinical nodal status
What matters in breast cancer trials
Study design
Hormone receptor-positive, HER2-positive and triple-negative breast cancers behave differently and are treated differently, so most trials enrol one subtype or stratify by it. That makes receptor status and HER2 testing results eligibility-critical data: they must be recorded as structured values, verified against pathology reports and available to the randomisation design as stratification factors.
In the neoadjuvant setting, the endpoint arrives months later at surgery, when the pathologist reports whether any invasive cancer remains in the breast and lymph nodes. Recording that result on a dedicated pathology form, with the definition of pCR used by the protocol, avoids the classic problem of pCR being inferred from free-text reports.
Adjuvant trials follow participants for many years for recurrence and survival. Follow-up visits thin out over time, and remote completion of quality of life questionnaires keeps participants engaged without extra clinic visits. See EORTC QLQ-C30 for the core cancer questionnaire.
| Assessment | Scr | C1 | C3 | C6 | Surgery | Adj | FU yr 1-5 |
|---|---|---|---|---|---|---|---|
| Receptor status | |||||||
| Breast imaging | |||||||
| Pathology (pCR) | |||||||
| Cardiac function | |||||||
| QoL (ePRO) | |||||||
| Recurrence status |
Stratification
Set the arms, block size and stratification factors (such as hormone receptor status or nodal status) once at setup. Allocation happens automatically at enrolment, the same way at every site, and every allocation is logged in the audit trail.
Baseline severity: moderate
Block 7 of 12
Baseline severity: severe
Block 4 of 12
Baseline severity: moderate
Block 6 of 12
Subject 01-0048 randomized
BlindedRandomization no.
R-0166
Treatment arm
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Emergency unblinding
Built in for blinded designs, when participant safety requires it.
Safety
Investigators grade adverse events with CTCAE on the AE log, with the minimum dataset enforced, while participants report symptoms weekly with PRO-CTCAE on their phones. Serious events raise routed safety alerts and are signed off under an electronic signature.
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Causality is required because the event is serious.
Set up receptor status forms and stratified randomisation in the free sandbox.
Endpoints by setting
| Setting | Typical primary endpoint | What the eCRF must capture |
|---|---|---|
| Neoadjuvant | Pathologic complete response (pCR) | Surgery date, pathology result in breast and nodes, pCR definition used; residual cancer burden if part of the protocol. |
| Adjuvant | Invasive disease-free survival (iDFS) | Recurrence type and date, second primary cancers and deaths, using standardised event definitions. |
| Metastatic | Progression-free survival | Target and non-target lesions at each assessment, RECIST 1.1 response, date of progression. |
| All settings | Overall survival, safety, quality of life | Survival status at follow-up, CTCAE-graded AEs, PRO questionnaires. |
Standardised definitions for adjuvant breast cancer endpoints (the STEEP criteria) help keep event classification consistent across trials.
Study build
ER, PR and HER2 with test method and result, verified against pathology.
Chosen and configured before the first randomisation.
pCR, iDFS or PFS definitions written into forms and help text.
LVEF assessments scheduled where HER2-targeted therapy is used.
RECIST 1.1 forms and imaging schedule for metastatic trials.
Recurrence, survival and remote quality of life questionnaires.
The absence of residual invasive cancer in the breast and lymph nodes at surgery after neoadjuvant therapy. State the exact definition used (for example ypT0/is ypN0) in the protocol.
HER2-targeted therapies can affect heart function, so protocols usually schedule LVEF assessments before and during treatment.
Pathologic complete response in neoadjuvant trials, invasive disease-free survival in adjuvant trials, and progression-free and overall survival in metastatic disease, alongside safety and quality of life.
As structured fields (ER, PR, HER2 with test details), verified against pathology reports and available as stratification factors.
Yes. Stratification factors are set at setup and applied automatically at enrolment.
Follow-up visits on the schedule with windows, and quality of life questionnaires completed remotely on participants' phones.
Yes, in the free sandbox with every feature.
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