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

November 8, 2010
June 22, 2011
September 2010
September 2011   (final data collection date for primary outcome measure)
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%
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%
Complete list of historical versions of study NCT01329640 on ClinicalTrials.gov Archive Site
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:

  1. Tumor measurements using MRI of the Breast
  2. Pathologic complete response
  3. Progression-free survival
  4. Overall survival
Efficacy [ Time Frame: From the beginning of treatment until sugery, progression and death ] [ Designated as safety issue: Yes ]

Efficacy will be assessed by:

  1. Tumor measurements using MRI of Breast
  2. Pathologic complete response
  3. Progression-free survival
  4. Overall survival
Not Provided
Not Provided
 
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced HER2-positive Breast Cancer
Device: 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
Other Name: Metronomic chemotherapy with trastuzumab
Experimental: Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide
Intervention: Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
September 2012
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01329640
TraQ-Me 01
No
Clinical Research Department, State of Sao Paulo Cancer Institute
University of Sao Paulo
Fundação Faculdade de Medicina
Not Provided
University of Sao Paulo
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP