A
Indication details
- Combined Agent(s)
- Standard endocrine therapy (aromatase inhibitors and/or antiestrogens with or without ovarian suppression)
- Control Arm
- Standard endocrine therapy
- Treatment setting
- In combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor positive, HER2- negative, node positive early breast cancer at high risk of recurrence and a Ki-67 score >20% In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone agonist
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- HR+ HER2- node-positive Ki-67 score ≥20%
- Trial Name
- monarchE
- NCT Number
- NCT03155997
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2021 FDA expansion to indication March 2023
- Comment
- FDA approval is only for Ki-67 ≥20%
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS
- Form(s)
- Form 1
Outcome Data
- DFS Control
- 3-year 79.0%
- DFS Gain
- 3-year 7.1%
- DFS HR
- 0.63 (0.49-0.80)
Adjustments
- Toxicity Comment
-
Acute toxicity
Final Score (after adjustments)
- Final curative score
-
A
- Comment
-
OS immature
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 307
- Scorecard version
- 1
- Issue date
- 10.12.2021
- Last update
- 03.02.2023
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.