Can a common chemo drug be matched to tumor genetics?
NCT ID NCT03096418
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study gives paclitaxel (Taxol) to 50 women with breast cancer before surgery to see if tumors with high chromosomal instability respond better. Researchers will measure tumor shrinkage and drug levels in the tumor. The goal is to find biomarkers that predict who benefits most from this chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paclitaxel (Taxol)
- What this could lead to
- If successful, this could help doctors predict which breast cancer patients will benefit most from paclitaxel before surgery, personalizing treatment.
- What could go wrong
- This is a small, early-phase study focused on biomarkers, not a treatment trial. Results may not change practice or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2017
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women with pathologically demonstrated breast cancer * Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel. * Patients must not have metastatic disease on staging work-up per institutional guidelines. * A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor (preferred) or lymph node. A minimum of 8 slides must be available. * The primary tumor or lymph node must be readily biopsied by surgery or radiology teams. * 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 if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians. * Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted. * Patients must have adequate organ and marrow function as determined by the treating oncologist. * Patient must be willing to undergo additional biopsy of breast tumor or lymph node. * Patient must have the ability and willingness to sign a written informed consent document. * Women of childbearing potential (per institutional policy) must agree to use effective contraception as discussed with treating oncologist for the duration of the study. Exclusion Criteria: * 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 as determined by treatment physician. * 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University of Iowa Health Care/Holden Comprehensive Cancer Center
RECRUITINGIowa City, Iowa, 52242, United States
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University of Wisconsin Carbone Cancer Center
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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