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

NCT ID: NCT01329627

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-08-31

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.

Conditions

Locally Advanced HER2-negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel/doxorubicin/cyclophosphamide

Group Type: EXPERIMENTAL

Paclitaxel/doxorubicin/cyclophosphamide

Intervention Type: DRUG

Metronomic chemotherapy as described below:

1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by;

2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.

Paclitaxel/doxorubicin/cyclophosphamide

Intervention Type: DRUG

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.

Interventions

Paclitaxel/doxorubicin/cyclophosphamide

Metronomic chemotherapy as described below:

1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by;

2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Metronomic chemotherapy; Metronomic chemotherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação Faculdade de Medicina

OTHER

Sponsor Role: collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

State of Sao Paulo Cancer Institute

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NP 50/2010 - TAME

Identifier Type: -

Identifier Source: org_study_id