Breast CancerNCT00537173
Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer
An observational study of Breast Cancer, run by Hoosier Cancer Research Network at 4 sites in United States.
Trial summary
This trial provides a unique opportunity in that it combines genomic, proteomic and pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To date no other trials have analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. 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?
- Core Biopsy, Blood Collection and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2007to Aug 2009
- 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 population is limited to patients with advanced breast cancer who are receiving paclitaxel + Avastin
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent, locally advanced (that is not amenable to resection with curative intent), or metastatic disease.
- Patients must consent to have a biopsy performed to obtain fresh tissue or be able to identify a FFPE tissue block in which tissue samples can be obtained to complete the testing for this study.
- Planned chemotherapy regimen of paclitaxel and Avastin for the treatment of metastatic breast cancer.
- Females age > 18 years
- Written informed consent and HIPAA authorization for release of personal health information.
Who cannot join
- Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer.
- Hormonal therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks prior to study entry.
- Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months prior to study entry.
- Breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin.
- Patients must not have had a major surgical procedure within 4 weeks prior to study entry. (Placement of vascular access device, and breast biopsy, will not be considered major surgery.)
- Patients must not have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days of starting protocol therapy.
Show all 20Show fewer
- Patients must not have had radiation within 2 weeks prior to study entry.
- Previously radiated area(s) must not be the only site of disease for study entry.
- Patients must not have a history of bleeding diathesis or have used anticoagulant therapy within 10 days of study entry. (Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed.)
- Patients with a history of deep vein thrombosis or pulmonary embolism are not eligible.
- Aspirin usage (> 325 mg/day) or other nonsteroidal anti-inflammatory medications known to inhibit platelet function daily are not allowed within 10 days prior to study entry.
- Patients currently using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
- Patients must not have a history of TIA or CVA within 6 months prior to study entry.
- Patients must not have a history or radiologic evidence of CNS metastases including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement (head CT or MRI must be obtained within 6 weeks prior to study entry).
- Patients must not have a non-healing wound or fracture.
- Patients must not have a hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies.
- Females must not be pregnant or breastfeeding. Females of childbearing potential must use an accepted and effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 3 month period thereafter.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
- Urine protein: creatinine (UPC) ratio > 1.0 at baseline or urine protein dipstick > 2+.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Baylor College of Medicine - Methodist Breast Center
Houston, Texas, 77030
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Horizon Oncology Center
Lafayette, Indiana, 47905
About this study
Official title: Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
This trial provides a unique opportunity in that it combines genomic, proteomic and pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To date no other trials have 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, we expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, we 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 multi-center study.
Sample Collection:
- Core biopsy
- Blood sample 28-day Cycle Treatment Regimen:
- Paclitaxel 90 mg/m2 IV D1, 8, and 15
- Avastin 10 mg/kg IV D1 and 15
ECOG Performance Status of 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- Platelet count > 100,000/mm³
- Absolute neutrophil count > 1200/mm³
- PTT < 1.5 x upper limit of normal
- INR < 1.5 x upper limit of normal
Hepatic:
- Total bilirubin < 1.5 mg/dL
- SGOT (AST) < 2 x upper limit of normal
Renal: Not specified
Cardiovascular:
- Clinically significant cardiovascular or cerebrovascular disease including prior myocardial infarction (within 6 months prior to study entry), unstable angina, Grade II or greater peripheral vascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, hypertensive crises, hypertensive encephalopathy or uncontrolled hypertension (SBP>150, DBP>100).
- Conditions
- Breast Cancer
- Being tested
- Core Biopsy, Blood Collection, Paclitaxel, Avastin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core BiopsyProcedure or surgery
biopsy
Blood CollectionProcedure or surgery
Blood/serum sample
PaclitaxelDrug
Paclitaxel 90 mg/m2 IV, day 1, 8 and 15
AvastinDrug
Avastin 10 mg/kg IV, day 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Paclitaxel 90 mg/m2 IV D1, 8, and 15 + Avastin 10 mg/kg IV, day 1 and 15 Receives: Procedure: Core Biopsy; Procedure: Blood Collection; Drug: Paclitaxel; Drug: Avastin |
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 paclitaxel + Avastin in patients with advanced breast cancer
Measured: 36 months
Secondary outcomes (1)
To correlate serum and tumor proteomic profiles with response; To compare serum and tissue proteomic analyses; To compare genomic and proteomic profiles; 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 posted28 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Lack of Accrual
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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 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, University of Colorado, Denver, Baylor University, McGill University
- Investigators
- George Sledge, M.D., Principal investigator, Hoosier Oncology Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537173
- Sponsor's protocol ID
- HOG COE-02
- Other IDs
- DoD Grant BC030400
- Status last verified
- Jan 2017
- First submitted
- 26 Sep 2007
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
- ClinicalTrials.gov ID
- NCT00537173
- Acronym / sponsor ID
- HOG COE-02
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of Accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- United States Department of Defense, Indiana University, University of Colorado, Denver, Baylor University, McGill University
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Sep 2007 (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.
This trial provides a unique opportunity in that it combines genomic, proteomic and pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To date no other trials have 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, we expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, we expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.
Detailed description
OUTLINE: This is a multi-center study.
Sample Collection:
- Core biopsy
- Blood sample 28-day Cycle Treatment Regimen:
- Paclitaxel 90 mg/m2 IV D1, 8, and 15
- Avastin 10 mg/kg IV D1 and 15
ECOG Performance Status of 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- Platelet count > 100,000/mm³
- Absolute neutrophil count > 1200/mm³
- PTT < 1.5 x upper limit of normal
- INR < 1.5 x upper limit of normal
Hepatic:
- Total bilirubin < 1.5 mg/dL
- SGOT (AST) < 2 x upper limit of normal
Renal: Not specified
Cardiovascular:
- Clinically significant cardiovascular or cerebrovascular disease including prior myocardial infarction (within 6 months prior to study entry), unstable angina, Grade II or greater peripheral vascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, hypertensive crises, hypertensive encephalopathy or uncontrolled hypertension (SBP>150, DBP>100).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Procedure: Core Biopsy, Procedure: Blood Collection, Drug: Paclitaxel, Drug: AvastinPaclitaxel 90 mg/m2 IV D1, 8, and 15 + Avastin 10 mg/kg IV, day 1 and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is limited to patients with advanced breast cancer who are receiving paclitaxel + Avastin
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent, locally advanced (that is not amenable to resection with curative intent), or metastatic disease.
- Patients must consent to have a biopsy performed to obtain fresh tissue or be able to identify a FFPE tissue block in which tissue samples can be obtained to complete the testing for this study.
- Planned chemotherapy regimen of paclitaxel and Avastin for the treatment of metastatic breast cancer.
- Females age > 18 years
- Written informed consent and HIPAA authorization for release of personal health information.
Key exclusion criteria (20 listed)
- Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer.
- Hormonal therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks prior to study entry.
- Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months prior to study entry.
- Breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin.
- Patients must not have had a major surgical procedure within 4 weeks prior to study entry. (Placement of vascular access device, and breast biopsy, will not be considered major surgery.)
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 |
|---|---|---|
| Core Biopsybiopsy | Procedure or surgery | Arm 1 |
| Blood CollectionBlood/serum sample | Procedure or surgery | Arm 1 |
| PaclitaxelPaclitaxel 90 mg/m2 IV, day 1, 8 and 15 | Drug | Arm 1 |
| AvastinAvastin 10 mg/kg IV, day 1 and 15 | Drug | Arm 1 |
Primary outcome
To correlate tumor gene expression (genomic profile) with response to paclitaxel + Avastin in patients with advanced breast cancer
Time frame: 36 months
1 secondary outcome
To correlate serum and tumor proteomic profiles with response; To compare serum and tissue proteomic analyses; To compare genomic and proteomic profiles; 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: Lack of Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
George Sledge, M.D. principal investigator
Hoosier Oncology Group, Inc.
4 sites in 1 country: 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 4 sites in United States.
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 5 inclusion and 20 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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: Lack of Accrual). 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 paclitaxel + Avastin 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 25 Jan 2017.