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3

Indication details

Control Arm
Standard chemotherapy
Therapeutic Indication
Treatment of patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or MBC who have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless unsuitable for these treatments
Tumour Sub-type
Breast Cancer
Tumour Stage
Advanced
Tumour Sub-Group
HER2- g-BrCa+ve
Trial Name
EMBRACA
NCT Number
NCT01945775
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval
EMA Approval
EMA (CHMP) April 2019 EC decision June 2019

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
5.6 months
PFS Gain
3 months
PFS HR
0.54 (0.41-0.71)
OS Control
19.5 months
OS Gain
−0.2 months
OS HR
0.85 (0.67-1.07) Not significant (mature)

Adjustments

QoL Comment
QoL was an exploratory endpoint

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
165
Scorecard version
1
Issue date
20.04.2020
Last update
26.04.2024
Talazoparib EMBRACA

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Talazoparib EMBRACA

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
3
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Treatment of patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or MBC who have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless unsuitable for these treatments
Talazoparib
Standard 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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