An observational study in Breast Cancer, sponsored by Hoosier Cancer Research Network. Terminated at 11 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-09.
Sponsored by Hoosier Cancer Research Network · Observational
The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.
OUTLINE: This is a 4 arm, multi-center study.
Sample Collection:
Treatment Regimens (Investigator/Patient Discretion):
Performance status \& Organ Function:
Performance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP).
Life Expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Not specified
Renal: Not specified
Cardiovascular: Not specified
Pulmonary: Not specified
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 80 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoosier Cancer Research Network is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study limited to patients with breast cancer.
Planned chemotherapy with one of the following regimens:
Exclusion Criteria:
Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
Procedure: Biopsy · Procedure: Serum Collection · Procedure: Urine Collection · Drug: Doxorubicin · Drug: Cyclophosphamide
Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
Procedure: Biopsy · Procedure: Serum Collection · Procedure: Urine Collection · Drug: Capecitabine
Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
Procedure: Biopsy · Procedure: Serum Collection · Procedure: Urine Collection · Drug: Vinorelbine
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
Procedure: Biopsy · Procedure: Serum Collection · Procedure: Urine Collection · Drug: Gemcitabine
core biopsy
serum collection
urine collection
Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
Time frame: 36 months
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
Time frame: 36 months
To compare serum and tissue proteomic analyses.
Time frame: 36 months
To compare genomic and proteomic profiles.
Time frame: 36 months
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
Time frame: 36 months
This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Hoosier Cancer Research Network