Trial Information

Topoisomerase 2-Alpha (TOPO2A) Genomic Alterations And Immunohistochemical Expression as Well as Chromosome 17 Polysomy In Advanced or Recurrent Endometrial Carcinoma Treated With Anthracycline-Based Therapy

OBJECTIVES:

- Determine the frequency of topoisomerase 2-alpha (TOPO2A) gene copy number alterations
(including deletions, gains, and amplification), immunohistochemical expression, and
chromosome 17 polysomy in tumor tissue samples from patients with advanced or recurrent
endometrial carcinoma treated with anthracycline-based therapy on GOG-0177.

- To assess the relationship between TOPO2A gene copy number alterations, TOPO2A protein
expression, chromosome 17 polysomy, and HER2 status in tumor tissue samples from these
patients.

- To assess the association between TOPO2A status (TOPO2A gene copy number alterations
and TOPO2A protein expression), or chromosome 17 polysomy and clinical covariates
(e.g., age, race/ethnicity, cell type, histologic grade, disease stage, regimen type).

- To assess the association between TOPO2A status or chromosome 17 polysomy with measures
of clinical outcome including response, progression-free survival, and overall survival
of patients treated with this regimen.

- To evaluate the potential identification of cut points for TOPO2A protein expression
with potential prognostic value in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and
expression and chromosome 17 polysomy by FISH and IHC.

Clinical information associated with each endometrial carcinoma sample (e.g., age,
race/ethnicity, cell type, histologic grade, disease stage, and regimen type) is also
collected.