Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer (TAME-01)

Instituto do Cancer do Estado de São Paulo

Status and phase

Terminated

Phase 2

Conditions

Locally Advanced HER2-negative Breast Cancer

Treatments

Drug: Paclitaxel/doxorubicin/cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01329627

NP 50/2010 - TAME

Details and patient eligibility

About

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.

Enrollment

12 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Locally advanced breast cancer diagnosed by guided core biopsy
T > 2 cm (any N), or any T and node positive (needle biopsy is required)
Non-metastatic disease assessed by computed tomography and bone scintigraphy
Histological grade 2 and Ki67 > 15% or
Histological grade 3 or
Any triple negative (TN) or
Inflammatory breast cancer (IBC)
Normal left ventricular ejection fraction (LVEF)
HER2-negative disease

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 as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
LVEF value below institutional limits of normal
Predominant lobular carcinoma histology
Grade 1 tumors
Detected or suspicious distant metastasis
Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
Male sex
HER2-positive breast cancer