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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by University of Sao Paulo.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Fundação Faculdade de Medicina

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01329640

First received: November 8, 2010

Last updated: June 22, 2011

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	November 8, 2010
Last Updated Date	June 22, 2011
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 31, 2011)	INCIDENCE OF FEBRILE NEUTROPENIA [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ] INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%
Original Primary Outcome Measures ^ICMJE (submitted: April 5, 2011)	INCIDENCE OF FEBRILE NEUTROPENIA [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ] INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL NO HIGHER THAN 10%
Change History	Complete list of historical versions of study NCT01329640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 31, 2011)	TUMOR SIZE [ Time Frame: From the beginning of treatment until surgery, disease progression or death ] [ Designated as safety issue: Yes ] Efficacy will be assessed by: Tumor measurements using MRI of the Breast Pathologic complete response Progression-free survival Overall survival
Original Secondary Outcome Measures ^ICMJE (submitted: April 5, 2011)	Efficacy [ Time Frame: From the beginning of treatment until sugery, progression and death ] [ Designated as safety issue: Yes ] Efficacy will be assessed by: Tumor measurements using MRI of Breast Pathologic complete response Progression-free survival Overall survival
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Locally Advanced HER2-positive Breast Cancer
Intervention ^ICMJE	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 Other Name: Metronomic chemotherapy with trastuzumab
Study Arm (s)	Experimental: Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide Intervention: Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	25
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01329640
Other Study ID Numbers ^ICMJE	TraQ-Me 01
Has Data Monitoring Committee	No
Responsible Party	Clinical Research Department, State of Sao Paulo Cancer Institute
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Fundação Faculdade de Medicina
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top