Breast CancerPhase 2NCT00088829
Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
A Phase 2 study testing paclitaxel, microarray analysis and biopsy in people with Breast Cancer, run by Georgetown University at 1 site in United States.
Trial summary
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment. PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast… 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?
- paclitaxel, microarray analysis and biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Histologically confirmed infiltrating carcinoma of the breast
- Unresected disease
- High-risk (> 50% risk of relapse) disease, including any of the following high-risk markers:
- Estrogen receptor- and progesterone receptor- negative
- Palpable axillary lymph nodes
- Grade 3 histology
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- S phase fraction > 10%
- Ki67 > 30%
- Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel
- HER2/neu negative or positive
- Hormone receptor status:
- Not specified
- Menopausal status
- Known
- Performance status
- ECOG 0-2
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1. 5 times normal (except for patients with known Gilbert's disease)
- Creatinine ≤ 1.5 times normal
Who cannot join
- uncontrolled congestive heart failure
- myocardial infarction within the past 6 months
- unstable angina
- uncontrolled hypertension
- pregnant or nursing
- serious bacterial, viral, or fungal infection requiring ongoing treatment
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- severe peripheral neuropathy
- poor psychiatric risk
- history of any other known serious co-morbid medical or psychiatric condition
- prior cytotoxic therapy for breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer: Identifying Factors Predictive of a Response to Paclitaxel
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.
PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status.
- Determine a standard protocol template for gene microarray analysis, in terms of the timing and method of collecting tissue samples, before and after administration of neoadjuvant paclitaxel in these patients.
- Determine the safety and efficacy of tissue sampling in these patients.
Secondary
- Identify gene(s) or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients.
- Identify gene(s) or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients.
- Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug.
- Develop, preliminarily, a statistical model utilizing individual genes and/or gene clusters that can best predict response to paclitaxel in these patients.
OUTLINE: This is a pilot, multicenter study.
Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment. Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel, upon completion of course 1, and either upon completion of the last course (in patients with clinical or radiographic evidence of residual disease) or during definitive breast surgery. Biopsy samples are analyzed for gene expression by gene microarray analysis.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel, microarray analysis, biopsy, neoadjuvant therapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IA breast cancer, stage IB breast cancer, HER2-negative breast cancer, HER2-positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
subjects will receive paclitaxel neoadjuvantly
microarray analysisGenetic
subjects will have a biopsy to collect tissue for gene microarray analysis
biopsyProcedure or surgery
All subjects will have a biopsy to collect tissue
neoadjuvant therapyProcedure or surgery
paclitaxel is given neoadjuvantly
PaclitaxelDrug
Also called Taxol
All patients will receive paclitaxel neoadjuvantly
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | Paclitaxel given before surgery Receives: Drug: paclitaxel; Genetic: microarray analysis; Procedure: biopsy; Procedure: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
Due to the early termination of the study, this data for this outcome was not collected.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startApr 2001
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Minetta C. Liu, MD, Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088829
- Sponsor's protocol ID
- CDR0000368453
- Other IDs
- P50CA058185, P30CA051008, GUMC-00310
- Status last verified
- May 2018
- First submitted
- 4 Aug 2004
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer: Identifying Factors Predictive of a Response to Paclitaxel
- ClinicalTrials.gov ID
- NCT00088829
- Acronym / sponsor ID
- CDR0000368453
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IA breast cancer, stage IB breast cancer, HER2-negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2001
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Aug 2004 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.
PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status.
- Determine a standard protocol template for gene microarray analysis, in terms of the timing and method of collecting tissue samples, before and after administration of neoadjuvant paclitaxel in these patients.
- Determine the safety and efficacy of tissue sampling in these patients.
Secondary
- Identify gene(s) or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients.
- Identify gene(s) or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients.
- Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug.
- Develop, preliminarily, a statistical model utilizing individual genes and/or gene clusters that can best predict response to paclitaxel in these patients.
OUTLINE: This is a pilot, multicenter study.
Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment. Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel, upon completion of course 1, and either upon completion of the last course (in patients with clinical or radiographic evidence of residual disease) or during definitive breast surgery. Biopsy samples are analyzed for gene expression by gene microarray analysis.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: paclitaxel, Genetic: microarray analysis, Procedure: biopsy, Procedure: neoadjuvant therapyPaclitaxel given before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed infiltrating carcinoma of the breast
- Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel
- HER2/neu negative or positive
- Hormone receptor status:
- Menopausal status
Key exclusion criteria (10 listed)
- uncontrolled congestive heart failure
- myocardial infarction within the past 6 months
- unstable angina
- uncontrolled hypertension
- pregnant or nursing
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 |
|---|---|---|
| paclitaxelsubjects will receive paclitaxel neoadjuvantly | Drug | Paclitaxel |
| microarray analysissubjects will have a biopsy to collect tissue for gene microarray analysis | Genetic | Paclitaxel |
| biopsyAll subjects will have a biopsy to collect tissue | Procedure or surgery | Paclitaxel |
| neoadjuvant therapypaclitaxel is given neoadjuvantly | Procedure or surgery | Paclitaxel |
| PaclitaxelAlso: TaxolAll patients will receive paclitaxel neoadjuvantly | Drug | Paclitaxel |
Primary outcome
Overall Response
Time frame: 3 months
Due to the early termination of the study, this data for this outcome was not collected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Minetta C. Liu, MD principal investigator
Lombardi Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel, microarray analysis and biopsy in people with Breast Cancer, run by Georgetown University at 1 site 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 20 inclusion and 10 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response (time frame: 3 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 11 Jul 2018.