C
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Breast Cancer
- Tumour Sub-type
- Early Breast Cancer
- Tumour Sub-Group
- HER2+
- Tumour stage
- Neoadjuvant
- Combined Agent(s)
- Trastuzumab + docetaxel
- Control Arm
- Trastuzumab + docetaxel (Randomised phase II study)
- Treatment Setting
- Neo-adjuvant HER2 overexpressed invasive ductal breast
- Trial Name
- NeoSphere
Primary Outcome(s)
- Primary Outcome(s)
- pCR
- Evaluated Outcome
- pCR
- Form(s)
- Form 1
Outcome Data
- PFS HR
- NS
- pCR Control
- 0.28999999999999998
- pCR Gain
- 46% vs 29%
Final Score (after adjustments)
- Final curative score
- C
- Comment
- EMA (CHMP) December 2012 EC decision February 2013
FDA approval October 2013 - Issue date
- 11.12.2018
- Release date
- 11.12.2018
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; 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; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression