Clinical trial · Observational
Defining an Exposure Target for Weekly Paclitaxel Infusion in Breast Cancer Patients
NCT02338115CI-TRIAL-00027316completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective observational study is to understand the relationship between paclitaxel exposure and development of peripheral neuropathy during treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel 80mg/m2 weekly x 12 weeks | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Weekly paclitaxel treatment group
- description
- Breast cancer patients initiating paclitaxel 80mg/m2 weekly x 12 weeks for curative treatment will be followed prospectively for collection of samples and longitudinal neuropathy data.
- interventionNames
- Drug: Paclitaxel 80mg/m2 weekly x 12 weeks
Primary outcomes (1)
- measure
- Severe neuropathy
- timeFrame
- During 12 cycles of paclitaxel treatment (12 weeks for most patients but longer for patients who have treatment delays. Expected maximum 16 weeks of treatment)
- description
- Increase in sensory scale of PRO measure of 5 points or more
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of invasive breast cancer * Systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per PI discretion) * 80 mg/m2 1-hour infusions weekly for up to 12 weeks * Female sex -\>18 years old * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Any prior or concurrent treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum, bortezomib, or thalidomide. Note that concurrent biologic treatment with trastuzumab/pertuzumab for HER2+ patients or prior treatment with Adriamycin/cyclophosphamide are not reasons for exclusion. * Distant metastatic disease * Concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent * History of allergic reaction to paclitaxel or cremophor EL * Current signs or symptoms of severe peripheral neuropathy * Known family history of hereditary peripheral neuropathy or Charcot-Marie-Tooth disease * Known current pregnancy
References
Publications (1)
- DERIVEDNguyen-Hoang N, Liu Y, Henry NL, Pai MP, Zhu HJ, Hertz DL. Quantitation of Plasma Proteins to Predict Taxane-Induced Peripheral Neuropathy. JCO Precis Oncol. 2025 Jan;9:e2400380. doi: 10.1200/PO-24-00380. Epub 2025 Jan 31. PMID 39889244