2
Indication details
- Control Arm
- Single arm study (Phase II)
- FDA Therapeutic Indication
- HER2-positive breast cancer that is metastatic (has spread to other parts of the body) or cannot be removed by surgery. HER2-positive means that the cancer cells produce a protein called HER2 in large quantities on their surface, which makes the tumour cells grow more quickly. Used on its own in patients who have received one or more HER2-targeted treatments
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- DESTINY-Breast01
- NCT Number
- NCT03248492
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval December 2019
- EMA Approval
- EMA (CHMP) December 2020 EC decision January 2021
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 16.4 months
- ORR
- 60.9%
- DoR
- 14.8 months
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
52.2% Grade 3+ toxicity 2% toxic fatalities
Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- 1-
- Non-curative score
-
2
- Comment
-
EMA (CHMP) December 2020 EC decision January 2021
FDA approval December 2019
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 164
- Scorecard version
- 1
- Issue date
- 20.04.2020
- Last update
- 02.03.2023
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.