Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Locally Advanced HER2-positive Breast Cancer

Intervention / Treatment
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* Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide<br> | Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide<br>* Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by; Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks<br>* Other names: Metronomic chemotherapy with trastuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INCIDENCE OF FEBRILE NEUTROPENIA | INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10% | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TUMOR SIZE | Efficacy will be assessed by: Tumor measurements using MRI of the Breast Pathologic complete response Progression-free survival Overall survival | From the beginning of treatment until surgery, disease progression or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metronimic chemotherapy, Locally Advanced HER2-positive Breast Cancer