5
Indication details
- Control Arm
- Physician’s choice of single agent ChT
- FDA Therapeutic Indication
- Treatment of patients with unresectable or metastatic TNBC who have received ≥2 prior systemic therapies, ≥1 of them for advanced disease
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- Triple-negative
- Trial Name
- ASCENT
- NCT Number
- NCT02574455
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA accelerated approval April 2020 and regular approval April 2021
- EMA Approval
- EMA CHMP (October) 2021 EC decision November 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS full population
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 1.7 months
- PFS Gain
- 3.1 months
- PFS HR
- 0.43 (0.35-0.54)
- OS Control
- 6.9 months
- OS Gain
- 4.9 months
- OS HR
- 0.51 (0.41-0.62)
Adjustments
- QoL Comment
-
QoL improved
Score (after adjustments)
- Preliminary non-curative score
-
4
- QoL adjustment
- 1+
- Non-curative score
-
5
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 271
- Scorecard version
- 1
- Issue date
- 21.05.2021
- Last update
- 26.04.2024
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.