3
Indication details
- Control Arm
- Investigator's choice chemotherapy (Capecitabine, Paclitaxel, Nab-Paclitaxel)
- Therapeutic Indication
- EMA: Trastuzumab deruxtecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. FDA: Trastuzumab deruxtecan for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, that has progressed on one or more endocrine therapies in the metastatic setting.
- Tumour Sub-type
- Breast cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- HER2-low, HR+, HER2-ultralow
- Trial Name
- DESTINY-Breast06
- NCT Number
- NCT04494425
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval January 2025
- EMA Approval
- EMA (CHMP) February 2025. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- PFS as primary endpoint and OS as secondary endpoint in HR+, HER2-low
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.1 months
- PFS Gain
- 5.1 months
- PFS HR
- 0.62 (0.51-0.74) P<0.001
- OS HR
- Immature
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 486
- Scorecard version
- 1
- Issue date
- 07.02.2025
- Last update
- 28.02.2025
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.