Breast CancerNCT00235235
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
An observational study of Breast Cancer, run by Hoosier Cancer Research Network at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Biopsy, Serum Collection and Urine Collection
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2005to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study limited to patients with breast cancer.
Who may be able to join
- 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:
- Doxorubicin 60 mg/m2 + 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 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527
Baylor College of Medicine - Methodist Breast Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Mary Lou Mayer, M.D.
Indianapolis, Indiana, 46227
Community Regional Cancer Center
Indianapolis, Indiana, 46256
Arnett Cancer Care
Lafayette, Indiana, 47904
Horizon Oncology Center
Lafayette, Indiana, 47905
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
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
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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Biopsy, Serum Collection, Urine Collection, Doxorubicin, Cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
core biopsy
Serum CollectionProcedure or surgery
serum collection
Urine CollectionProcedure or surgery
urine collection
DoxorubicinDrug
Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
CyclophosphamideDrug
Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
CapecitabineDrug
Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
VinorelbineDrug
Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
GemcitabineDrug
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle Receives: Procedure: Biopsy; Procedure: Serum Collection; Procedure: Urine Collection; Drug: Doxorubicin; Drug: Cyclophosphamide | |
| B | Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle Receives: Procedure: Biopsy; Procedure: Serum Collection; Procedure: Urine Collection; Drug: Capecitabine | |
| C | Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle Receives: Procedure: Biopsy; Procedure: Serum Collection; Procedure: Urine Collection; Drug: Vinorelbine | |
| D | Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle Receives: Procedure: Biopsy; Procedure: Serum Collection; Procedure: Urine Collection; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
Measured: 36 months
Secondary outcomes (4)
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
Measured: 36 months
To compare serum and tissue proteomic analyses.
Measured: 36 months
To compare genomic and proteomic profiles.
Measured: 36 months
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Indiana University, Walther Cancer Institute
- Responsible party
- Principal investigator, Kathy Miller, MD, Hoosier Cancer Research Network
- Investigators
- Kathy Miller, M.D., Study chair, Hoosier Oncology Group, LLCGeorge Sledge, M.D., Principal investigator, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235235
- Sponsor's protocol ID
- HOG COE-01
- Other IDs
- Department of Defense BC030400
- Status last verified
- Dec 2015
- First submitted
- 6 Oct 2005
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00235235
- Acronym / sponsor ID
- HOG COE-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding terminated
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- United States Department of Defense, Indiana University, Walther Cancer Institute
- Study start
- Sep 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: Biopsy, Procedure: Serum Collection, Procedure: Urine Collection, Drug: Doxorubicin, Drug: CyclophosphamideDoxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle |
| B | – | Procedure: Biopsy, Procedure: Serum Collection, Procedure: Urine Collection, Drug: CapecitabineCapecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle |
| C | – | Procedure: Biopsy, Procedure: Serum Collection, Procedure: Urine Collection, Drug: VinorelbineVinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle |
| D | – | Procedure: Biopsy, Procedure: Serum Collection, Procedure: Urine Collection, Drug: GemcitabineGemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study limited to patients with breast cancer.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsycore biopsy | Procedure or surgery | A, B, C, D |
| Serum Collectionserum collection | Procedure or surgery | A, B, C, D |
| Urine Collectionurine collection | Procedure or surgery | A, B, C, D |
| DoxorubicinDoxorubicin 60 mg/m2 day 1 of every 21-day cycle | Drug | A |
| CyclophosphamideCyclophosphamide 600 mg/m2 day 1 of every 21-day cycle | Drug | A |
| CapecitabineCapecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle | Drug | B |
| VinorelbineVinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle | Drug | C |
| GemcitabineGemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle | Drug | D |
Primary outcome
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
Time frame: 36 months
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Funding terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Miller, M.D. study chair
Hoosier Oncology Group, LLC
George Sledge, M.D. principal investigator
Hoosier Oncology Group, LLC
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoosier Cancer Research Network at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.