Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01476111

Enrollment

117

Registered

2011-11-22

Start date

2011-12-31

Completion date

2014-07-31

Last updated

2015-03-09

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

Conditions

Neoplasms, Breast

Keywords

tumor antigens, observational, breast cancer, biomarkers, Neoadjuvant

Brief summary

This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patient has 18 years of age or older at the time of consent. * The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study. * The patient has a histologically or cytologically confirmed primary invasive breast cancer. * The patient has provided written informed consent before any new information or new material is provided to the Sponsor. * The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer. * The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.

Exclusion criteria

Not applicable.

Design outcomes

Primary

Measure	Time frame
The presence of a specific predictive gene expression signature in tumor tissues	At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of immune infiltration in tumor tissues	At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of other candidate biomarkers in tumor tissues	At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The pathological response (complete response or partial response) in the breast.	At definitive surgery which may be up to 30 weeks post randomization.
Disease free interval	Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
Disease free survival	Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.
Overall survival	Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.

Countries

Belgium, Germany, Italy, Russia, United Kingdom, United States

Outcome results