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

Primary Purpose

Locally Advanced HER2-positive Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced HER2-positive Breast Cancer focused on measuring Metronimic chemotherapy, Locally Advanced HER2-positive Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Cancer do Estado de Sao Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

TUMOR SIZE
Efficacy will be assessed by: Tumor measurements using MRI of the Breast Pathologic complete response Progression-free survival Overall survival

Full Information

First Posted
November 8, 2010
Last Updated
May 20, 2014
Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Fundação Faculdade de Medicina
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1. Study Identification

Unique Protocol Identification Number
NCT01329640
Brief Title
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Fundação Faculdade de Medicina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced HER2-positive Breast Cancer
Keywords
Metronimic chemotherapy, Locally Advanced HER2-positive Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
Other Intervention Name(s)
Metronomic chemotherapy with trastuzumab
Intervention Description
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
Primary Outcome Measure Information:
Title
INCIDENCE OF FEBRILE NEUTROPENIA
Description
INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
TUMOR SIZE
Description
Efficacy will be assessed by: Tumor measurements using MRI of the Breast Pathologic complete response Progression-free survival Overall survival
Time Frame
From the beginning of treatment until surgery, disease progression or death

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil

12. IPD Sharing Statement

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

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