Dr Gnant - ESMO Oral Presentation 08
Dr Gnant - ESMO Oral Presentation 08
Dr Gnant - ESMO Oral Presentation 08
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ABCSG-12 Trial Design<br />
• Accrual 1999-2006<br />
• 1,803 premenopausal breast cancer pts<br />
• Endocrine-responsive (ER + and/or PgR + )<br />
• Stage I and II, < 10 positive nodes<br />
• No chemotherapy except neoadjuvant<br />
• Treatment duration: 3 years<br />
Surgery<br />
(+ RT)<br />
Goserelin<br />
3.6 mg q 28 d<br />
DFS = Disease-free survival; RFS = Relapse-free survival;<br />
OS = Overall survival; BMFS = Bone metastasis-free survival;<br />
TAM = Tamoxifen; ANA = Anastrozole; ZOL = Zoledronic acid.<br />
Randomize<br />
1 : 1 : 1: 1<br />
2 Key Comparisons:<br />
TAM vs ANA<br />
ZOL vs no ZOL<br />
TAM 20 mg/d<br />
TAM 20 mg/d<br />
+ ZOL 4 mg q 6 mo<br />
ANA 1 mg/d<br />
ANA 1 mg/d<br />
+ ZOL 4 mg q 6 mo<br />
5