Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer
Phase 2
Terminated
- Conditions
- Locally Advanced HER2-negative Breast Cancer
- Interventions
- Drug: Paclitaxel/doxorubicin/cyclophosphamide
- Registration Number
- NCT01329627
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paclitaxel/doxorubicin/cyclophosphamide Paclitaxel/doxorubicin/cyclophosphamide -
- Primary Outcome Measures
Name Time Method Incidence of febrile neutropenia 18 weeks Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
- Secondary Outcome Measures
Name Time Method Efficacy From the beginning of treatment until surgery, progression and death Efficacy will be assessed by:
1. Tumor measurements using MRI
2. Pathologic complete response
3. Progression-free survival
4. Overall survival
Trial Locations
- Locations (1)
State of Sao Paulo Cancer Institute
🇧🇷Sao Paulo, Brazil