Clinical trial · Interventional
Preoperative Herceptin and Navelbine for Breast Cancer
Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer
NCT00148681CI-TRIAL-00036543completedPhase 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 find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.
Conditions
Conditions (3)
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 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
| Navelbine | Drug | Vinorelbine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lower Risk Regimen
- interventionNames
- Drug: Herceptin
- Drug: Navelbine
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Higher Risk Regimen
- interventionNames
- Drug: Herceptin
- Drug: Navelbine
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * EGOG performance status of 0-1 * HER2 overexpressing (IHC 3+ or FISH +) * Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible * Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible * 18 years of age or older Exclusion Criteria: * Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine * Pregnant or lactating women * Uncontrolled infections, including AIDS * History or symptoms diagnostic of systemic connective tissue or inflammatory disease * Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma. * Left ventricular ejection fraction \< 50% * 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.