Clinical trial · Interventional
Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
A Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer: Identifying Factors Predictive of a Response to Paclitaxel
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator left institution
Summary
Brief summary (as posted)
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment. PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel
- description
- Paclitaxel given before surgery
- interventionNames
- Drug: paclitaxel
- Genetic: microarray analysis
- Procedure: biopsy
- Procedure: neoadjuvant therapy
Primary outcomes (1)
- measure
- Overall Response
- timeFrame
- 3 months
- description
- Due to the early termination of the study, this data for this outcome was not collected.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion:
* Histologically confirmed infiltrating carcinoma of the breast
* Unresected disease
* High-risk (\> 50% risk of relapse) disease, including any of the following high-risk markers:
* Estrogen receptor- and progesterone receptor- negative
* Palpable axillary lymph nodes
* Grade 3 histology
* S phase fraction \> 10%
* Ki67 \> 30%
* Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel
* HER2/neu negative or positive
* Hormone receptor status:
* Not specified
Menopausal status
* Known
Performance status
* ECOG 0-2
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1. 5 times normal (except for patients with known Gilbert's disease)
* Creatinine ≤ 1.5 times normal
Exclusion:
* uncontrolled congestive heart failure
* myocardial infarction within the past 6 months
* unstable angina
* uncontrolled hypertension
* pregnant or nursing
* serious bacterial, viral, or fungal infection requiring ongoing treatment
* severe peripheral neuropathy
* poor psychiatric risk
* history of any other known serious co-morbid medical or psychiatric condition
* prior cytotoxic therapy for breast cancerReferences
Publications (0)
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