文档介绍：Phase III paring AC-T with AC-TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: Second Interim Efficacy Analysis
Study sponsored by Sanofi-Aventis
Support from Genentech
Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Pawlicki M, Chan A, Smylie M, Liu M, Falkson C, Pinter T, Fornander T, Shiftan T, Valero V, Von Minckwitz G, Mackey J, Tabah-Fisch I, Buyse M, Lindsay MA, Riva A, Bee V, Pegram M, Press M, Crown J, on behalf of the BCIRG 006 Investigators.
After the presentation these slides will be available at: .
The HER2 Alteration
IHC
Southern
Northern
Western
Slamon et al. Science 1987,1989
Global Project Coordinator
Valerie Bee
4 x AC 60/600 mg/m2
4 x Docetaxel
100 mg/m2
6 x Docetaxel and Carboplatin
75 mg/m2 AUC 6
1 Year Trastuzumab
N=3,222
1 Year Trastuzumab
ACT
ACTH
TCH
Her 2+
(Central FISH)
N+
or high
risk N-
4 x AC 60/600 mg/m2
4 x Docetaxel
100 mg/m2
Slamon D., SABCS 2006
BCIRG 006
Stratified by Nodes and Hormonal Receptor Status
Endpoints
Primary
Disease-free Survival
Secondary
Overall Survival
Toxicity
Pathologic & Molecular Markers
Patient characteristics
Randomized (n=3,222)
AC-T n=1,073
AC-TH n=1,074
TCH n=1,075
%
%
%
Age < 50 years
52
52
54
KPS = 100
80
79
80
Mastectomy
60
63
60
Radiotherapy
63
61
63
Hormonotherapy
50
51
51
Enrollment: April 2001 to March 2004
Tumor Characteristics
Randomized (n=3,222)
AC-T n=1,073
AC-TH n=1,074
TCH n=1,075
Number of nodes +
%
%
%
0
29
29
29
1 – 3
38
38
39
4 – 10
22
24
23
> 10
11
9
10
Tumor Size (cm)
%
%
%
2
41
38
40
> 2 and 5
53
55
54
> 5
6
7
6
ER and/or PR +
54
54
54
Crossover
After the trastuzumab efficacy results were announced in April ’05, to date:
A total of 17 patients (%) of 1,073 randomized to the the ITT control arm (AC-T) crossed-over to receive trastuzumab
Leaving % of the control arm enrollment intact for subsequent DFS, OS and pariso