A
Indication details
- Combined Agent(s)
- ChT (paclitaxel + carboplatin)
- Control Arm
- Placebo plus ChT (paclitaxel + carboplatin)
- FDA Therapeutic Indication
- In combination with ChT as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Neoadjuvant high-risk early-stage
- Tumour Sub-Group
- Triple-negative
- Trial Name
- KEYNOTE-522
- NCT Number
- NCT03036488
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval July 2021
- EMA Approval
- EMA (CHMP) April 2022 EC Decision May 2022
Primary Outcome(s)
- Primary Outcome(s)
- PCR, EFS in ITT
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 3-year 86.9%
- OS Gain
- 3-year 2.8%
- OS HR
- Not significant (immature)
- pCR Control
- 51.2%
- pCR Gain
- 13.6%
- EFS control
- 3-year 76.8%
- EFS gain
- 3-year 7.7%
- EFS HR
- 0.63 (0.48-0.82)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 285
- Scorecard version
- 1
- Issue date
- 31.08.2021
- Last update
- 29.08.2023
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.