A
Indication details
- Combined Agent(s)
- Non-steroidal aromatase inhibitor (NSAI)
- Control Arm
- Non-steroidal aromatase inhibitor (NSAI)
- Therapeutic Indication
- EMA/FDA: Ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack for the same indication.
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Early with high risk of recurrence
- Tumour Sub-Group
- HR-positive, HER2-negative
- Trial Name
- NATALEE
- NCT Number
- NCT03701334
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2024
- EMA Approval
- EMA (CHMP) October 2024. Pending EC decision (recommendations on extensions)
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS
- Form(s)
- Form 1
Outcome Data
- DFS Control
- 3-year: 87.1%
- DFS Gain
- 3-year: 3.3%
- DFS HR
- 0.75 (0.62 - 0.91). P = 0.003 in the ITT population (prespecified stopping boundary at interim = 0.0256)
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
18.9% discontinued due to AE
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 468
- Scorecard version
- 1
- Issue date
- 07.11.2024
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.