Clinical trial · Interventional
Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery
Neoadjuvant Therapy and Biomarker Analysis of Stage II and III Breast Cancer With Docetaxel/Capecitabine and Celecoxib Followed by Doxorubicin/Cyclophosphamide and Celecoxib
NCT00665457CI-TRIAL-00069584terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study drug was removed from the market and low enrollment.
Summary
Brief summary (as posted)
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be removed by surgery.
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 (19)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| celecoxib | Drug | Celecoxib | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: Patients undergo definitive surgery (either modified radical mastectomy or lumpectomy combined with axillary node dissection). Patients may also undergo adjuvant radiotherapy and hormonal therapy at the discretion of multidisciplinary breast team.
- interventionNames
- Biological: filgrastim
- Drug: capecitabine
- Drug: celecoxib
- Drug: cyclophosphamide
- Drug: docetaxel
- Drug: doxorubicin hydrochloride
- Genetic: gene expression analysis
- Genetic: polymorphism analysis
- Genetic: protein expression analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: imaging biomarker analysis
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic evidence of invasive breast cancer * Stage II-III disease * Resectable disease * Must have a primary tumor estimated by mammogram, ultrasound or palpation to be ≥ 3 cm and/or palpable axillary nodes \> 1 cm for whom neoadjuvant chemotherapy is appropriate * ECOG performance status 0-1 * Absolute granulocyte count \> 2,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Serum bilirubin \< 1.5 times upper limit of normal (ULN) * Serum creatinine \< 1.5 times ULN * Fertile patients must use effective contraception during and for 3 months after completion of study therapy * At least 2 weeks since prior treatment with cyclooxygenase (COX)-2 inhibitors Exclusion Criteria: * Not pregnant or nursing/negative pregnancy test * No allergies to sulfa medication, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) * No uncontrolled concurrent illness that might jeopardize the patient's ability to receive the chemotherapy program outlined in this protocol, including any of the following: * Active infection requiring intravenous antibiotics * Symptomatic congestive heart failure * Unstable angina pectoris * Serious, uncontrolled cardiac arrhythmia * No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years * No prior chemotherapy or radiation therapy for ipsilateral breast cancer * No concurrent sorivudine or brivudine to treat herpes simplex or herpes zoster viral infections * No concurrent participation in another therapeutic clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.