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

NCT01329640 | Terminated Phase 2

• 1 other identifier: NP 17/2010 TraQ-Me 01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Metronimic chemotherapy; Locally Advanced HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• INCIDENCE OF FEBRILE NEUTROPENIA

  INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%

  18 weeks

Secondary Outcomes (1)

• TUMOR SIZE

  From the beginning of treatment until surgery, disease progression or death

Study Arms (1)

Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide

EXPERIMENTAL

Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide

Interventions

Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide 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

Also known as: Metronomic chemotherapy with trastuzumab

Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Fundação Faculdade de Medicina: collaborator

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: April 6, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

BR (1)