Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

4

Indication details

Combined Agent(s)
Trastuzumab + docetaxel
Control Arm
Trastuzumab + docetaxel + placebo
Therapeutic Indication
HER2-positive locally recurrent unresectable or metastatic breast cancer with no prior anti-HER2 therapy or ChT for metastatic disease
Tumour Sub-type
Breast Cancer
Tumour Stage
Locally recurrent unresectable or metastatic
Tumour Sub-Group
HER2+
Trial Name
CLEOPATRA
NCT Number
NCT00567190
Trial Phase
Phase III

Approval details

FDA Approval
FDA approved
EMA Approval
EMA (CHMP) December 2012 EC decision February 2013

Primary Outcome(s)

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

Outcome Data

PFS Control
12.4 months
PFS Gain
6.3 months
PFS HR
0.62 (0.52-0.75)
OS Control
40.8 months
OS Gain
16.3 months
OS HR
0.69 (0.58-0.82)

Adjustments

QoL Comment
No improvement in global QoL

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
4
Scorecard version
1
Issue date
11.12.2018
Last update
14.08.2023
Pertuzumab CLEOPATRA

PRELIMINARY SCORE

OS

ADJUSTMENTS

No improvement in global QoL
Pertuzumab CLEOPATRA

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
HER2-positive locally recurrent unresectable or metastatic breast cancer with no prior anti-HER2 therapy or ChT for metastatic disease
Pertuzumab + Trastuzumab + docetaxel
Trastuzumab + docetaxel + placebo

My watchlist

    pdf
    pptx

    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.

    This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

    For more detailed information on the cookies we use, please check our Privacy Policy.

    Customise settings
    • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.