Breast CancerEarly Phase 1NCT01263613
Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer
A Early Phase 1 study testing tumor biopsy and blood draw in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine if the investigators are able to locate and measure certain characteristics in breast cancer tumors that have been treated with paclitaxel that may correlate to how well the cancer will respond to the chemotherapy. 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?
- tumor biopsy and blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2013
- Phase
- Early Phase 1
- 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
Who may be able to join
- Women with pathologically demonstrated breast cancer.
- Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. Generally this would include:
- Women with node-positive breast cancer based on ultrasound-guided axillary node biopsy, regardless of hormone or HER2 receptor status.
- Women with greater than 1 cm breast cancer on imaging (mammogram, ultrasound, breast MRI) who are HER2+ or triple negative (ER-PR-HER2-).
- Women who are candidates for standard paclitaxel chemotherapy from treating oncologist for any other reason.
- Patients must not have metastatic disease on staging work-up with chest imaging, CBC, and liver function studies.
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- A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor. A minimum of 5 unstained slides must be available.
- The primary tumor must be readily able to be biopsied by palpation.
- The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality.
- Subjects may not have had prior systemic chemotherapy or targeted therapy regimens administered for treatment of their current breast cancer.
- Age >18 years. Breast cancer is rare in women < 18 years old. The safety of paclitaxel in pediatric population with breast cancer has not been established, therefore these patients are ineligible.
- Patients must have adequate organ and marrow function
- Patient must be willing to undergo additional biopsy of breast tumor.
- Patient must have the ability and willingness to sign a written informed consent document.
Who cannot join
- Patients who have had systemic chemotherapies, targeted therapies or radiotherapy for any cancer within 5 years prior to entering the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil).
- Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications.
- Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
The purpose of this study is to determine if the investigators are able to locate and measure certain characteristics in breast cancer tumors that have been treated with paclitaxel that may correlate to how well the cancer will respond to the chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- tumor biopsy and blood draw
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor biopsy and blood drawProcedure or surgery
tumor biopsy and blood draw during and after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Other | biopsy Receives: Procedure: tumor biopsy and blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of measuring biomarkers in breast tumors 20 hours after administration of the first dose of paclitaxel chemotherapy.
Measured: 1 year
Secondary outcomes (5)
Measure drug levels in breast tumors 20 hours after administration of paclitaxel
Measured: 1 year
Determine feasibility of correlating drug levels with biomarkers including mitotic index, aneuploidy, and Ki67
Measured: 1 year
Determine feasibility of correlating pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, and Ki67.
Measured: 1 year
Determine the feasibility of obtaining circulating tumor cells (CTCs) for analysis including evaluation for mitosis.
Measured: 1 year
Compare biomarkers from tissue samples obtained 20 hours after administration of paclitaxel with tissue obtained at the time of surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark E Burkard, MD, PhD, Principal investigator, University of Wisconsin Paul P. Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263613
- Sponsor's protocol ID
- OS10103
- Other IDs
- A534260, SMPH\MEDICINE\HEM-ONC, 2010-0357, P30CA014520
- Status last verified
- Apr 2014
- First submitted
- 16 Dec 2010
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zasadil LM, Andersen KA, Yeum D, Rocque GB, Wilke LG, Tevaarwerk AJ, Raines RT, Burkard ME, Weaver BA. Cytotoxicity of paclitaxel in breast cancer is due to chromosome missegregation on multipolar spindles. Sci Transl Med. 2014 Mar 26;6(229):229ra43. doi: 10.1126/scitranslmed.3007965.
PubMed 24670687
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01263613
- Acronym / sponsor ID
- OS10103
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Dec 2010 (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 purpose of this study is to determine if the investigators are able to locate and measure certain characteristics in breast cancer tumors that have been treated with paclitaxel that may correlate to how well the cancer will respond to the chemotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Other | Procedure: tumor biopsy and blood drawbiopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women with pathologically demonstrated breast cancer.
- Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. Generally this would include:
- Women with node-positive breast cancer based on ultrasound-guided axillary node biopsy, regardless of hormone or HER2 receptor status.
- Women with greater than 1 cm breast cancer on imaging (mammogram, ultrasound, breast MRI) who are HER2+ or triple negative (ER-PR-HER2-).
- Women who are candidates for standard paclitaxel chemotherapy from treating oncologist for any other reason.
Key exclusion criteria (6 listed)
- Patients who have had systemic chemotherapies, targeted therapies or radiotherapy for any cancer within 5 years prior to entering the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil).
- Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications.
- Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| tumor biopsy and blood drawtumor biopsy and blood draw during and after chemotherapy | Procedure or surgery | Biopsy |
Primary outcome
Determine feasibility of measuring biomarkers in breast tumors 20 hours after administration of the first dose of paclitaxel chemotherapy.
Time frame: 1 year
5 secondary outcomes
Measure drug levels in breast tumors 20 hours after administration of paclitaxel
Time frame: 1 year
Determine feasibility of correlating drug levels with biomarkers including mitotic index, aneuploidy, and Ki67
Time frame: 1 year
Determine feasibility of correlating pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, and Ki67.
Time frame: 1 year
Determine the feasibility of obtaining circulating tumor cells (CTCs) for analysis including evaluation for mitosis.
Time frame: 1 year
Compare biomarkers from tissue samples obtained 20 hours after administration of paclitaxel with tissue obtained at the time of surgery.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Results publication: PubMed 24670687Zasadil LM, Andersen KA, Yeum D, Rocque GB, Wilke LG, Tevaarwerk AJ, Raines RT, Burkard ME, Weaver BA. Cytotoxicity of paclitaxel in breast cancer is due to chromosome missegregation on multipolar spindles. Sci Transl Med. 2014 Mar 26;6(229):229ra43. doi: 10.1126/scitranslmed.3007965.
- University of Wisconsin Carbone Cancer CenterLink 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.
Mark E Burkard, MD, PhD principal investigator
University of Wisconsin Paul P. Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing tumor biopsy and blood draw in people with Breast Cancer, run by University of Wisconsin, Madison 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 14 inclusion and 6 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: finished, as of the sponsor's last update on 19 Nov 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine feasibility of measuring biomarkers in breast tumors 20 hours after administration of the first dose of paclitaxel chemotherapy. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263613, which also lists 1 linked publication.
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 19 Nov 2019.