Clinical trial · Interventional
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer
NCT00148668CI-TRIAL-00009954completedPhase 2Results postedClinicalTrials.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 find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive 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 |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
| Navelbine | Drug | Vinorelbine | ALIAS |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Herceptin/navelbine
- interventionNames
- Drug: Herceptin
- Drug: Navelbine
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Taxotere/carboplatin/herceptin
- interventionNames
- Drug: Herceptin
- Drug: Taxotere
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with stage II or III breast cancer * HER-2 positive tumors * Older than 18 years of age * Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1. * ANC \> 1,500/mm3 * Hemoglobin \> 9gm/dl * Platelets \> 100,000mm3 * Creatinine \< 2mg/dl * Glucose \< 200mg/dl * Bilirubin \< 1.5 x ULN Exclusion Criteria: * Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy. * Pregnant or breast-feeding women * Serious illness, or medical or psychiatric condition * Uncontrolled infections * Active or severe cardiovascular or pulmonary disease * Patients with left ventricular ejection fraction \< 50% * Peripheral neuropathy of any etiology that exceeds grade 1 * Prior history of malignancy * Uncontrolled diabetes
References
Publications (0)
Data not yet available
No reference posted for this study.