Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)
Phase 2
Terminated
- Conditions
- Locally Advanced HER2-positive Breast Cancer
- Registration Number
- NCT01329640
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method INCIDENCE OF FEBRILE NEUTROPENIA 18 weeks INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%
- Secondary Outcome Measures
Name Time Method TUMOR SIZE From the beginning of treatment until surgery, disease progression or death Efficacy will be assessed by:
1. Tumor measurements using MRI of the Breast
2. Pathologic complete response
3. Progression-free survival
4. Overall survival
Trial Locations
- Locations (1)
Instituto do Cancer do Estado de Sao Paulo
🇧🇷Sao Paulo, Brazil