Clinical trial · Interventional
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)
Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer
NCT01329640CI-TRIAL-00014599terminatedPhase 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 evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-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 |
|---|---|---|---|
| Locally Advanced HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide
- interventionNames
- Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
Primary outcomes (1)
- measure
- INCIDENCE OF FEBRILE NEUTROPENIA
- timeFrame
- 18 weeks
- description
- INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%
Secondary outcomes (1)
- measure
- TUMOR SIZE
- timeFrame
- From the beginning of treatment until surgery, disease progression or death
- description
- Efficacy will be assessed by: 1. Tumor measurements using MRI of the Breast 2. Pathologic complete response 3. Progression-free survival 4. Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of locally advanced breast cancer * T \> 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size is less than 2cm) * Non-metastatic disease confirmed by computerized tomography and bone scan * HER2 positive by IHC (+++) and/or Fish (+) according to international definitions (ASCO 2007) * Normal left ventricular ejection fraction (LVEF) * Indication of preoperative chemotherapy * multifocal tumors acceptable provided that the largest tumor is Her2-positive * ECOG 0-1 Exclusion Criteria: * Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast) * Clinically significant comorbidities such as cardiovascular diseases, COPD, renal or liver impairment, psychiatric disorders * LVEF value below institutional limits of normal range * Detected or suspected distant metastasis * Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin higher than ULN, alkaline phosphatase more than 1.5x ULN
References
Publications (0)
Data not yet available
No reference posted for this study.