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

Vera Jean Suman, Matthew J. Ellis, Cynthia X. Ma

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24 Citations (Scopus)

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.

Original languageEnglish (US)
Article number34
JournalChinese Clinical Oncology
Volume4
Issue number3
DOIs
StatePublished - 2015

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Neoadjuvant Therapy
Biomarkers
Breast Neoplasms
Recurrence
Phase III Clinical Trials
Therapeutics
Clinical Trials
Survival
fulvestrant
anastrozole

Keywords

  • Aromatase inhibitors (AIs)
  • Breast cancer
  • Postmenopausal

ASJC Scopus subject areas

  • Oncology

Cite this

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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.",
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