Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

NCT03096418 | Recruiting Phase 4 Results FDA Drug

• 7 other identifiers: UW16106NCI-2017-003382016-1489A534260SMPH\MEDICINE\HEM-ONCProtocol Version 10/10/20251R01CA284747-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• Response to Paclitaxel

  To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria

  Up to 3 months

Secondary Outcomes (9)

• Tumor Level Difference of Paclitaxel

  Up to 1 day

• Non-Tumor Level Difference of Paclitaxel

  Up to 1 day

• Paclitaxel Levels

  Up to 79 days

• Antimitotic Effects

  Up to 79 days

• Mitotic Index

  Baseline and 20 hours post-first dose

Study Arms (1)

Weekly Paclitaxel

EXPERIMENTAL

Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle. Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.

Also known as: Taxol

Weekly Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Iowa Health Care/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Related Publications (1)

• Scribano CM, Wan J, Esbona K, Tucker JB, Lasek A, Zhou AS, Zasadil LM, Molini R, Fitzgerald J, Lager AM, Laffin JJ, Correia-Staudt K, Wisinski KB, Tevaarwerk AJ, O'Regan R, McGregor SM, Fowler AM, Chappell RJ, Bugni TS, Burkard ME, Weaver BA. Chromosomal instability sensitizes patient breast tumors to multipolar divisions induced by paclitaxel. Sci Transl Med. 2021 Sep 8;13(610):eabd4811. doi: 10.1126/scitranslmed.abd4811. Epub 2021 Sep 8.

  PMID: 34516829 RESULT

Related Links

• UW Carbone Cancer Center Home Page

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Cancer Connect
• Organization: University of Wisconsin Carbone Cancer Center

clinicaltrials@cancer.wisc.edu

800-622-8922

Study Officials

• Marina Sharifi, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 30, 2017
• Study Start: March 13, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 16, 2026
• Results First Posted: October 13, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (2)