2
Indication details
- Combined Agent(s)
- Exemestane
- Control Arm
- Exemestane + placebo
- FDA Therapeutic Indication
- Treatment of HR+, HER2- advanced breast cancer, in combination with exemestane, in postmenpausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- BOLERO-2
- NCT Number
- NCT00863655
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval July 2012
- EMA Approval
- EMA (CHMP) June 2012 EC decision August 2012
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.2 months
- PFS Gain
- 4.6 months
- PFS HR
- 0.45 (0.38-0.54)
- OS Control
- 26.6 months
- OS Gain
- 4.4 months
- OS HR
- 0.89 (0.73-1.10) Not significant (mature)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
>10% increment in discontinuation due to AEs
Score (after adjustments)
- Preliminary non-curative score
-
3
- Only improved PFS mature data shows no OS advantage and no improved QoL
- 1-
- Non-curative score
-
2
- Comment
-
Downgrade by 1 point as only improved PFS mature data shows no OS advantage and no improved QoL
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 12
- Scorecard version
- 1
- Issue date
- 11.12.2018
- 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.