4
Indication details
- Control Arm
- Pysician's ChT choice (eribulin, capecitabine, gemcitabine, nab-paclitaxel, or paclitaxel)
- FDA Therapeutic Indication
- Treatment of patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- HER2-low
- Trial Name
- DESTINY-Breast04
- NCT Number
- NCT03734029
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2022
- EMA Approval
- EMA (CHMP) December 2022 EC decision February 2023
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS hierarchically tested
- Evaluated Outcome
- OS (all patients)
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.1 months
- PFS Gain
- 4.8 months
- PFS HR
- 0.50 (0.40–0.63)
- OS Control
- 16.8 months
- OS Gain
- 6.6 months
- OS HR
- 0.64 (0.49–0.84)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 351
- Scorecard version
- 1
- Issue date
- 22.09.2022
- Last update
- 20.12.2022
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.