Clinical trial · Interventional
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer
NCT00136539CI-TRIAL-00009495completedPhase 2ClinicalTrials.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 study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Cytoxan | Drug | Cyclophosphamide | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
| Taxol | Drug | Taxol | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
Secondary outcomes (1)
- measure
- To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have Stage II or III histologically diagnosed breast cancer * Primary invasive breast cancers that overexpress the HER2/neu oncogene * Age older than 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 * White blood cell (WBC) \> 4000/mm3 * Platelet count \> 100,000/mm3 * Bilirubin \< 1 x upper limit of normal (ULN) * SGOT \< 1 x ULN * Creatinine \< 1.5mg/dl * Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy Exclusion Criteria: * Excisional biopsy, sentinel node dissection or axillary node dissection. * Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant. * Pregnant or breast-feeding women * Uncontrolled infection * Active or severe cardiovascular or pulmonary disease * Peripheral neuropathy of any etiology that exceeds grade 1 * Prior history of malignancy treated without curative intent * Uncontrolled diabetes
References
Publications (0)
Data not yet available
No reference posted for this study.