3
Indication details
- Control Arm
- Investigator’s choice of chemotherapy (Eribulin, capecitabine, vinorelbine, or gemcitabine)
- Therapeutic Indication
- EMA: Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. FDA: Datopotamab deruxtecan for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
- Tumour Sub-type
- Breast cancer
- Tumour Stage
- Unresectable metastatic
- Tumour Sub-Group
- HR+, HER2-
- Trial Name
- TROPION-Breast01
- NCT Number
- NCT05104866
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval January 2025
- EMA Approval
- EMA (CHMP) January 2025. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.9 months
- PFS Gain
- 2.0 months
- PFS HR
- 0.63 (0.52 - 0.76) P < .0001
- OS HR
- 0.84 (0.62 - 1.14), NS, 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
- 488
- Scorecard version
- 1
- Issue date
- 24.02.2025
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.