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Investigation of the prognostic role of protein expression, mRNA levels, gene amplification and mutation of key cellular elements in patients with breast cancer treated with dose-dense sequential adjuvant chemotherapy

High-risk patients with operable breast cancer treated with adjuvant dose-dense sequential chemotherapy. A translational study of investigating biomarkers with prognostic value on disease-free survival and overall survival (HE10/10)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001043426
Enrollment
1054
Registered
2016-08-04
Start date
2016-02-01
Completion date
2016-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial is a retrospective translational research study evaluating biological material (archival tumor tissue and blood samples) of patients who received a widely used regimen recommended in NCCN guidelines v1.2016. Radiotherapy and anti-HER2 treatment were administered as indicated.

Interventions

This is a retrospective translational research study on breast cancer patients treated with dose-dense sequential adjuvant chemotherapy. FFPE tumor samples and blood samples were obtained between 2010 and 2013 at diagnosis and were collected from the treating institutions where they were stored for the purposes of this translational research study between 2/2016 and 6/2016 in order to evaluate the prognostic role of protein expression, mRNA levels, gene amplification and mutations of key cellula

This is a retrospective translational research study on breast cancer patients treated with dose-dense sequential adjuvant chemotherapy. FFPE tumor samples and blood samples were obtained between 2010 and 2013 at diagnosis and were collected from the treating institutions where they were stored for the purposes of this translational research study between 2/2016 and 6/2016 in order to evaluate the prognostic role of protein expression, mRNA levels, gene amplification and mutations of key cellular elements in association with measures of outcome (overall survival, disease-free survival). The follow-up of each patient will be at least 10 years from patient enrolement.

Sponsors

Hellenic Cooperative Oncology Group
Lead SponsorOther Collaborative groups

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pre and post menopausal patients with intermediate or high-risk operable breast cancer as defined by the “Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005. A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, B. Thurlimann, H.J. Senn & Panel Members, Annals of Oncology 16: 1569–1583, 2005 who received dose-dense sequential adjuvant chemotherapy.

Exclusion criteria

Documented residual or metastatic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026