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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Locally Advanced HER2-negative Breast Cancer
Intervention	Drug: Paclitaxel/doxorubicin/cyclophosphamide Drug: Paclitaxel/doxorubicin/cyclophosphamide
Phase	Phase 2
Sponsor	University of Sao Paulo
Responsible Party	University of Sao Paulo
ClinicalTrials.gov Identifier	NCT01329627
First Received	November 8, 2010
Last Updated	June 22, 2011
Last verified	September 2010

Tracking Information[ + expand ][ + ]

First Received Date	November 8, 2010
Last Updated Date	June 22, 2011
Start Date	August 2010
Estimated Primary Completion Date	August 2012
Current Primary Outcome Measures	Incidence of febrile neutropenia [Time Frame: 18 weeks] [Designated as safety issue: Yes]Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
Current Secondary Outcome Measures	Efficacy [Time Frame: From the beginning of treatment until surgery, progression and death] [Designated as safety issue: No]Efficacy will be assessed by: Tumor measurements using MRI Pathologic complete response Progression-free survival Overall survival

Descriptive Information[ + expand ][ + ]

Brief Title	Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer
Official Title	Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
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 Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Locally Advanced HER2-negative Breast Cancer
Intervention	Drug: Paclitaxel/doxorubicin/cyclophosphamide 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. Other Names: Metronomic chemotherapyDrug: Paclitaxel/doxorubicin/cyclophosphamide 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. Other Names: Metronomic chemotherapy
Study Arm (s)	Experimental: Paclitaxel/doxorubicin/cyclophosphamide

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	80
Estimated Completion Date	August 2012
Estimated Primary Completion Date	August 2011
Eligibility 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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT01329627
Other Study ID Numbers	TAME-01
Has Data Monitoring Committee	No
Information Provided By	University of Sao Paulo
Study Sponsor	University of Sao Paulo
Collaborators	Fundação Faculdade de Medicina
Investigators	Not Provided
Verification Date	September 2010

Locations[ + expand ][ + ]