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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer

Conditions
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Locally Advanced HER2-negative Breast Cancer

Intervention / Treatment
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* Drug: Paclitaxel/doxorubicin/cyclophosphamide
* Drug: Paclitaxel/doxorubicin/cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel/doxorubicin/cyclophosphamide<br> | Drug: Paclitaxel/doxorubicin/cyclophosphamide<br>* Metronomic chemotherapy as described below: Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.<br>* Other names: Metronomic chemotherapy;Drug: Paclitaxel/doxorubicin/cyclophosphamide<br>* Metronomic chemotherapy as described below: Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.<br>* Other names: Metronomic chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia | Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10% | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Efficacy will be assessed by: Tumor measurements using MRI Pathologic complete response Progression-free survival Overall survival | From the beginning of treatment until surgery, progression and death |