5
Indication details
- Combined Agent(s)
- Endocrine therapy
- Control Arm
- Placebo + endocrine therapy
- Therapeutic Indication
- Treatment of women with HR+, HER2 negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.. In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist.
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- MONALEESA-7
- NCT Number
- NCT02278120
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved July 2018
- EMA Approval
- EMA (CHMP) November 2018. EC decision January 2019. EMA (CHMP) extension of indication October 2024. EC decision December 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 13.0 months
- PFS Gain
- 10.8 months
- PFS HR
- 0.55 (0.44-0.69)
- OS Control
- 48.0 months
- OS Gain
- 10.7 months
- OS HR
- 0.76 (0.61-0.96)
Adjustments
- QoL Comment
-
Delayed deterioration of global QoL
Score (after adjustments)
- Preliminary non-curative score
-
4
- QoL adjustment
- 1+
- Non-curative score
-
5
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 158
- Scorecard version
- 1
- Issue date
- 20.04.2020
- Last update
- 14.08.2023
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.