DESTINY-Breast06
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Phase 3N = 866NCT04494425
- Population
- Hormone receptor-positive metastatic breast cancer with HER2-low or HER2-ultralow expression, after one or more lines of endocrine-based therapy and no chemotherapy for metastatic disease
- Design
- Phase 3 multicentre open-label randomised trial, 1:1 allocation to trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary endpoint was PFS by blinded independent central review among patients with HER2-low disease (IHC 1+ or 2+/ISH-); an exploratory HER2-ultralow group (IHC 0 with membrane staining) was also randomised.
- Primary endpoint
- PFS
- Arms
- Physician's choice of chemotherapy (control): Chemotherapy chosen by the physician
- Trastuzumab deruxtecan (experimental): Trastuzumab deruxtecan
- People
- Bardia A
PFSHR 0.62 (95% CI 0.52–0.75)Δ median PFS+5.1 months
Show the numbers
| Endpoint | Analysis | Trastuzumab deruxtecan | Physician's choice of chemotherapy | Effect |
|---|---|---|---|---|
| PFSHER2-low disease (713 patients)PFS by blinded independent central review | primaryBardia 2024 | median 13.2 months (11.4–15.2) | median 8.1 months (7–9) | HR 0.62 (95% CI 0.52–0.75)P<0.001Primary endpoint population. The abstract states the results were consistent in the exploratory HER2-ultralow population (153 patients) without giving the values. Overall survival data were immature. |
| Endpoint | Analysis | Trastuzumab deruxtecan | Physician's choice of chemotherapy | Effect |
|---|---|---|---|---|
| PFSHER2-low disease (713 patients)PFS by blinded independent central review | primaryBardia 2024 | median 13.2 months (11.4–15.2) | median 8.1 months (7–9) | HR 0.62 (95% CI 0.52–0.75)P<0.001Primary endpoint population. The abstract states the results were consistent in the exploratory HER2-ultralow population (153 patients) without giving the values. Overall survival data were immature. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.62 | 0.52–0.75 |
- Physician's choice of chemotherapy (control)
- Trastuzumab deruxtecan (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Physician's choice of chemotherapy | Trastuzumab deruxtecan |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 8 | 50.4% | 65.7% |
| 17 | 23.3% | 41.0% |
| 25 | 11.8% | 26.9% |
| 33 | 5.9% | 17.7% |