4
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Breast Cancer
- Tumour Sub-type
- Breast Cancer
- Tumour Sub-Group
- HER2+
- Tumour stage
- Unresectable or metastatic
- Combined Agent(s)
- ADT (androgen deprivation therapy)
- Control Arm
- Trastuzumab emtansine (T-DM1)
- Treatment Setting
- Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens
- Trial Name
- DESTINY-Breast03
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 6.8 months
- PFS Gain
- 22.0 months
- PFS HR
- 0.33 (0.26-0.43)
- OS Control
- 2-year 69.9%
- OS Gain
- 2-year 7.5%
- OS HR
- HR 0.64 (0.47-0.87) P=0.0037 (meets prespecified cutoff for significance P<0.008 at second interim analysis)
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Final non-curative Score
- 4
- Early stopping or crossover
- 1+
- Long-term plateau in the PFS curve
- ≥10% improvement at 2 years
- Comment
- EMA (CHMP) June 2022 EC decision August 2022
FDA regular approval May 2022 - Issue date
- 31.05.2022
- Release date
- 31.05.2022
- Last update
- 11.04.2023
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response.remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type