2
Indication details
- Combined Agent(s)
- Letrozole
- Control Arm
- Letrozole + placebo
- Therapeutic Indication
- EMA: Palbociclib for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. FDA: Palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- PALOMA-2
- NCT Number
- NCT01740427
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved February 2015
- EMA Approval
- EMA (CHMP) September 2016. EC decision November 2016
Primary Outcome(s)
- Primary Outcome(s)
- PFS (primary), OS (secondary)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 14.5 months
- PFS Gain
- 13.1 months
- PFS HR
- 0.56 (0.46-0.69)
- OS Control
- 51.2 months
- OS Gain
- 2.7 months
- OS HR
- 0.96 (0.78- 1.18)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Only improved PFS mature data shows no OS advantage and no improved QoL
- 1-
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 7
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 21.03.2025
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.