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Review
. 2015 Sep;4(3):34.
doi: 10.3978/j.issn.2304-3865.2015.09.01.

The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer

Vera Jean Suman  1 , Matthew J Ellis  2 , Cynthia X Ma  3
Affiliations
Review

The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer

Vera Jean Suman et al. Chin Clin Oncol. 2015 Sep.

Abstract

The Alliance for Clinical Trials in Oncology cooperative group has designed a phase III neoadjuvant clinical trial (ALTERNATE trial) which randomizes women with cT2-4 N0-3 M0 ER+/Her2- invasive breast cancer to either anastrozole, fulvestrant or its combination to assess a biomarker-driven treatment strategy to identify women with a low risk of disease recurrence. This strategy incorporates the findings that: higher expression of the proliferation marker, Ki67, after 2 weeks of neoadjuvant endocrine therapy (ET), is associated with poor recurrence-free survival, and that patients with surgical findings of pT1/2, pN0 disease, Ki67 ≤2.7% and ER Allred score of 3-8 after neoadjuvant ET have extremely low recurrence rates. We present a description and rationale for the design of this trial.

Keywords: Breast cancer; aromatase inhibitors (AIs); postmenopausal.

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Conflict of interest statement

Conflicts of Interest: The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Schema for neoadjuvant portion of ALTERNATE trial. mPEPI, modified PEPI score.
Figure 2
Figure 2
Schema for adjuvant portion of ALTERNATE trial.
See this image and copyright information in PMC

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