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2

Indication details

Combined Agent(s)
Exemestane
Control Arm
Exemestane + placebo
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
Everolimus BOLERO-2

PRELIMINARY SCORE

PFS

ADJUSTMENTS

No QoL benefit
Only improved PFS mature data shows no OS advantage and no improved QoL
Everolimus BOLERO-2

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
2
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
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
Everolimus + Exemestane
Exemestane + placebo

My watchlist

    pdf
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    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.

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