ABCSG-12 Trial Evaluation of Anastrozole vs. Tamoxifen in Premenopausal Women, Alone or In Combination With Zoledronic Acid

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ABCSG-12 Trial Evaluation of Anastrozole vs.
Tamoxifen in Premenopausal Women, Alone or In
Combination With Zoledronic Acid
Tamoxifen (TAM) 20 mg/d n 451
Anastrozole (ANA) 1 mg/d n 453
Randomized 1 1 1 1 n 1803 Goserelin
Long-term monitoring 5 years for recurrence
Tamoxifen (TAM) 20 mg/d Zoledronic Acid (ZOL)
4mg q6m n 449
Anastrozole (ANA) 1 mg/d Zoledronic Acid (ZOL)
4mg q6m n 450
Treatment duration 3 years
Key Endpoints Primary Disease-free survival
(DFS) at 5 years (TAM vs. ANA ZOL vs.
No-ZOL)? Secondary Recurrence-free survival
(RFS) at 5 years, Overall survival (OS) (TAM
vs. ANA ZOL vs. No-ZOL)?
Glossary of Terms Goserelin all four
arms treated with goserelin, which suppresses the
ovaries, resulting in the loss of
menstruation Disease-free survival (DFS)
length of time after randomization during which
patients had no local recurrence, contralateral
carcinoma, distant metastasis, secondary
carcinoma and/or death Relapse-free survival
(RFS) the length of time after randomization
during which patients had no local relapse,
contralateral carcinoma, distant metastasis
and/or secondary carcinoma Overall survival (OS)
percentage of people in a study or treatment
group who are alive for a given period of time
after treatment