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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

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