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

Locally Advanced HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329640
• Other study ID #: NP 17/2010 TraQ-Me 01
• Status: Terminated
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: May 20, 2014
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2014
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Comittee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced HER2-positive Breast Cancer

Intervention

Device:
• Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
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; Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	Fundação Faculdade de Medicina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INCIDENCE OF FEBRILE NEUTROPENIA	INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%	18 weeks	Yes
Secondary	TUMOR SIZE	Efficacy will be assessed by: Tumor measurements using MRI of the Breast; Pathologic complete response; Progression-free survival; Overall survival	From the beginning of treatment until surgery, disease progression or death	Yes