Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)

NCT ID: NCT01329640

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-09-30

Brief Summary

The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.

Conditions

Locally Advanced HER2-positive Breast Cancer

Study Design

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

Study Groups

Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide

Group Type: EXPERIMENTAL

Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide

Intervention Type: DEVICE

1. Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by;

2. Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks

Interventions

Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide

1. Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by;

2. Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks

Intervention Type: DEVICE

Other Intervention Names

Metronomic chemotherapy with trastuzumab

Eligibility Criteria

Inclusion Criteria

• Diagnosis of locally advanced breast cancer
• T > 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size is less than 2cm)
• Non-metastatic disease confirmed by computerized tomography and bone scan
• HER2 positive by IHC (+++) and/or Fish (+) according to international definitions (ASCO 2007)
• Normal left ventricular ejection fraction (LVEF)
• Indication of preoperative chemotherapy
• multifocal tumors acceptable provided that the largest tumor is Her2-positive
• ECOG 0-1

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 such as cardiovascular diseases, COPD, renal or liver impairment, psychiatric disorders
• LVEF value below institutional limits of normal range
• Detected or suspected distant metastasis
• Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin higher than ULN, alkaline phosphatase more than 1.5x ULN

• 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

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NP 17/2010 TraQ-Me 01

Identifier Type: -

Identifier Source: org_study_id