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
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.