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

Control Arm
Physician's choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) 
Therapeutic Indication
Treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting
Tumour Sub-type
Breast Cancer
Tumour Stage
Unresectable or metastatic
Tumour Sub-Group
HR-positive HER2-negative
Trial Name
TROPiCS-02
NCT Number
NCT03901339
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval February 2023
EMA Approval
EMA (CHMP) June 2023 EC decision August 2023

Primary Outcome(s)

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

Outcome Data

PFS Control
4.0 months
PFS Gain
1.5 months
PFS HR
0.66 (0.53-0.83)
OS Control
11.2 months
OS Gain
3.2 months
OS HR
0.79 (0.65-0.96)

Adjustments

QoL Comment
Delayed deterioration claimed, does not meet ESMO-MCBS QoL standards

Score (after adjustments)

Preliminary non-curative score

4

Non-curative score

4

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
374
Scorecard version
1
Issue date
20.03.2023
Last update
30.10.2023
Sacituzumab govitecan TROPiCS-02

PRELIMINARY SCORE

OS

ADJUSTMENTS

Delayed deterioration claimed, does not meet ESMO-MCBS QoL standards
Sacituzumab govitecan TROPiCS-02

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 adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting
Sacituzumab govitecan
Physician's choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) 

My watchlist

    pdf
    pptx

    Legend

    Information about symbols, abbrevations and color codes

    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.

    • Analytics cookies help us improve our website by collecting and reporting information on its usage.

    • We use marketing cookies to build a profile of you as a user through your actions on our site in order to better understand your interests and provide you with pertinent suggestions.