Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT00235235
Status:
TERMINATED
Last Update Posted:
2015-12-09
First Post:
2005-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Study Overview
Official Title:
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
OUTLINE: This is a 4 arm, multi-center study.
Sample Collection:
* Core Biopsy
* Serum
* Urine
Treatment Regimens (Investigator/Patient Discretion):
* Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
* Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
* Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
* Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
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
Sample Collection:
* Core Biopsy
* Serum
* Urine
Treatment Regimens (Investigator/Patient Discretion):
* Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
* Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
* Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
* Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Department of Defense BC030400 | REGISTRY | ClinicalTrials.Gov | View |