4
Indication details
- Combined Agent(s)
- Trastuzumab + docetaxel
- Control Arm
- Trastuzumab + docetaxel + placebo
- Therapeutic Indication
- Treatment of patients with HER2-positive metastatic or locally recurrent unresectable BC who have not received previous 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 approval June 2012
- 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
- 0.69 (0.59-0.81)
- 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
Score (after adjustments)
- Preliminary non-curative score
-
4
- 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
- 25.04.2024
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.