3
Indication details
- Combined Agent(s)
- Fulvestrant
- Control Arm
- Placebo + fulvestrant
- Therapeutic Indication
- Capivasertib with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally Advanced (Inoperable) or Metastatic
- Tumour Sub-Group
- PIK3CA/AKT1/PTEN- ; HR+ ; HER2-
- Trial Name
- CAPItello-291
- NCT Number
- NCT04305496
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2023
- EMA Approval
- EMA (CHMP) April 2024. EC decision June 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.1 months
- PFS Gain
- 4.2 months
- PFS HR
- 0.50 (0.38-0.65)
- OS Control
- Not reached
- OS Gain
- 0.69 (0.45-1.05) Not significant
Adjustments
- QoL Comment
-
Reviewed, but not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 409
- Scorecard version
- 1
- Issue date
- 05.12.2023
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.