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

Instituto do Cancer do Estado de São Paulo

Status and phase

Terminated

Phase 2

Conditions

Locally Advanced HER2-positive Breast Cancer

Treatments

Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01329640

NP 17/2010 TraQ-Me 01

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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