Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborator: Fundação Faculdade de Medicina
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

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