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A

Indication details

Control Arm
Chemotherapy
Therapeutic Indication
Patients with HER2-positive early breast cancer following surgery, ChT (neoadjuvant or adjuvant) and RT (if applicable)
Tumour Sub-type
Early Breast Cancer
Tumour Stage
Early
Tumour Sub-Group
HER2+
Trial Name
HERA
NCT Number
NCT00045032
Trial Phase
Phase III

Approval details

EMA Approval
EC decision May 2006

Primary Outcome(s)

Primary Outcome(s)
DFS
Evaluated Outcome
DFS
Form(s)
Form 1

Outcome Data

DFS Control
2-years DFS 77.4%
DFS Gain
8.40 %
DFS HR
0.54 (0.43-0.67)

Final Score (after adjustments)

Final curative score

A

Comment
Licensed biosimilar formulations are available for this medicine and this may improve accessibility and sustainability


Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
1
Scorecard version
1
Issue date
11.12.2018
Last update
03.08.2022
Trastuzumab HERA

PRELIMINARY SCORE

DFS

ADJUSTMENTS

Trastuzumab HERA

FINAL SCORE

A

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Patients with HER2-positive early breast cancer following surgery, ChT (neoadjuvant or adjuvant) and RT (if applicable)
Trastuzumab
Chemotherapy

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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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