A
Indication details
- Combined Agent(s)
- Standard endocrine therapy (aromatase inhibitors and/or antiestrogens with or without ovarian suppression)
- Control Arm
- Standard endocrine therapy
- FDA Therapeutic Indication
- Adjuvant treatment of adult patients with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Early with high risk of recurrence
- Tumour Sub-Group
- HR+ HER2- node-positive
- Trial Name
- monarchE
- NCT Number
- NCT03155997
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2021 FDA expansion to indication March 2023
- EMA Approval
- EMA (CHMP) February 2022 EC decision April 2022
- Comment
- EMA approval was based on data from Cohort 1 of the monarchE study; however, analysis of Cohort 1 was not a prespecified endpoint and the data are therefore not eligible for ESMO-MCBS scoring. Scoring is based on the ITT analysis. FDA: Ki-67 testing requirement removed on 3 March 2023.
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS
- Form(s)
- Form 1
Outcome Data
- OS HR
- 0.90 (0.75- 1.09) Immature, NS
- DFS Control
- 5-year: 76.0%
- DFS Gain
- 5-year: 7.6%
- DFS HR
- 0.68 (0.60-0.77)
Adjustments
- QoL Comment
-
QoL as secondary endpoint
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 371
- Scorecard version
- 1
- Issue date
- 03.02.2023
- Last update
- 22.03.2024
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.