Using paclitaxel to treat breast cancer with chromosomal instability

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

This study is testing if a chemotherapy drug called paclitaxel can help women with breast cancer that has different levels of chromosomal instability before they have surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Wisconsin, Madison (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Iowa City, Iowa and 1 other locations)
• Trial ID: NCT03096418 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of neoadjuvant paclitaxel chemotherapy in women with breast cancer, specifically focusing on tumors with varying levels of chromosomal instability (CIN). Participants will receive paclitaxel infusions on specific days over a 21-day cycle before surgery. The study aims to correlate paclitaxel levels and distribution with tumor response and various biomarkers, including mitotic index and aneuploidy. Additionally, it will assess whether tumors with high CIN respond better to treatment compared to those with low CIN.

Who should consider this trial

Good fit: Ideal candidates are women with pathologically confirmed breast cancer who are eligible for neoadjuvant paclitaxel chemotherapy.

Not a fit: Patients with metastatic breast cancer or those receiving other concurrent therapeutic agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for breast cancer patients with high chromosomal instability.

How similar studies have performed: Other studies have explored the effects of paclitaxel in breast cancer, but this specific focus on chromosomal instability is relatively novel.

Eligibility criteria

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.

Where this trial is running

Iowa City, Iowa and 1 other locations

• University of Iowa Health Care/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (Not_yet_recruiting)
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Marina Sharifi, MD, PhD — University of Wisconsin, Madison
• Study coordinator: Cancer Connect

Conditions Breast Neoplasm Female