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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

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