Clinical trial · Observational
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding terminated
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Serum Collection | Procedure | — | UNRESOLVED |
| Urine Collection | Procedure | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (4)
- label
- A
- description
- Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
- interventionNames
- Procedure: Biopsy
- Procedure: Serum Collection
- Procedure: Urine Collection
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- label
- B
- description
- Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
- interventionNames
- Procedure: Biopsy
- Procedure: Serum Collection
- Procedure: Urine Collection
- Drug: Capecitabine
- label
- C
- description
- Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease. * Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis. * Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST. * Planned chemotherapy with one of the following regimens: 1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle 2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle 3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle 4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle Exclusion Criteria: * No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation. * Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential. * Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy. * No breast-feeding.
References
Publications (0)
Data not yet available