Cardio-oncology & otherRandomised controlled trial
Safety of withdrawal of pharmacological treatment after recovery from HER2 therapy-related cardiac dysfunction: the HER-SAFE trial
- Randomised controlled trial
- open-label
- multicentre
Authors' conclusion
Among breast cancer survivors with recovered anti-HER2 CTRCD, HFT withdrawal was not associated with symptomatic events or significant between-group difference in LVEF at 12-months.
Study context
- Population
- Breast cancer survivors with recovered anti-HER2 cancer therapy-related cardiac dysfunction (CTRCD) (asymptomatic, LVEF ≥50%, normalised biomarkers)all female
- Participants
- 90 survivors
- Comparison
- Heart failure therapy (HFT) withdrawal vs continuation
- Withdrawaln = 46
- Continuationn = 44reference
- Primary endpoint
- Moderate or severe CTRCD event
- Follow-up
- 12 months
Primary result
Moderate or severe CTRCD
Between-group difference
2.2 pp
90% CI upper limit 9.4pp
Events by treatment group
Withdrawal
1 of 45
1 of 46
Continuation
0 of 44
0 of 44
As reported in the abstract
Secondary outcomes
| Outcome | between-group difference (%) (CI) | P value | |
|---|---|---|---|
| CMR-derived LVEF · 12 months | −0.8 (−2.0 to +0.4) | P = 0.21 | |
| −3−2−101Difference, % (linear scale) |
CMR-derived LVEF · 12 months
- LVEF remained stable in both arms
CV deaths, HF hospitalisations, symptomatic CTRCD
- No CV deaths, HF hospitalisations or symptomatic CTRCD occurred
Original publication
Safety of withdrawal of pharmacological treatment after recovery from HER2 therapy-related cardiac dysfunction: the HER-SAFE trial. Eur Heart J. Published 30 August 2026. doi:10.1093/eurheartj/ehag707
Summarised from the published abstract; every number is checked against it