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4

Indication details

Combined Agent(s)
Letrozole
Control Arm
Letrozole + placebo
Therapeutic Indication
Treatment of women with HR+, HER2 negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist
Tumour Sub-type
Breast Cancer
Tumour Stage
Advanced
Tumour Sub-Group
HR+ HER2-
Trial Name
MONALEESA-2
NCT Number
NCT01958021
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval March 2017
EMA Approval
EMA approval June 2017 EC decision August 2017

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

PFS Control
16 months
PFS Gain
9.3 months
PFS HR
0.57 (0.46-0.70)
OS Control
51.4 months
OS Gain
12.5 months
OS HR
0.76 (0.63-0.93)

Adjustments

QoL Comment
No global QoL benefit observed

Final Score (after adjustments)

Preliminary non-curative score

4

Final non-curative score

4

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
9
Scorecard version
1
Issue date
11.12.2018
Last update
14.08.2023
Ribociclib MONALEESA-2

PRELIMINARY SCORE

OS

ADJUSTMENTS

No improvement in global QoL
Ribociclib MONALEESA-2

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
4
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Treatment of women with HR+, HER2 negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist
Ribociclib + Letrozole
Letrozole + placebo

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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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