4
Indication details
- Control Arm
- Trastuzumab emtansine (T-DM1)
- FDA Therapeutic Indication
- Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- DESTINY-Breast03
- NCT Number
- NCT03529110
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA regular approval May 2022
- EMA Approval
- EMA (CHMP) June 2022 EC decision August 2022
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 6.8 months
- PFS Gain
- 22.0 months
- PFS HR
- 0.33 (0.26-0.43)
- OS Control
- 2-year 69.9%
- OS Gain
- 2-year 7.5%
- OS HR
- HR 0.64 (0.47-0.87) P=0.0037 (meets prespecified cutoff for significance P<0.008 at second interim analysis)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Early stopping or crossover
- 1+
- Long-term plateau in the PFS curve
- ≥10% improvement at 2 years
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 342
- Scorecard version
- 1
- Issue date
- 31.05.2022
- Last update
- 25.04.2024
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.