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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
  Purpose

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.


Condition Intervention Phase
Locally Advanced HER2-positive Breast Cancer
 Device: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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%


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329640

Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo
Sao Paulo, Brazil, 01246-000
Sponsors and Collaborators
University of Sao Paulo
Fundação Faculdade de Medicina
  More Information

No publications provided

Responsible Party: Clinical Research Department, State of Sao Paulo Cancer Institute
ClinicalTrials.gov Identifier: NCT01329640     History of Changes
Other Study ID Numbers: TraQ-Me 01
Study First Received: November 8, 2010
Last Updated: June 22, 2011
Health Authority: Brazil: National Comittee of Ethics in Research

Keywords provided by University of Sao Paulo:
Metronimic chemotherapy
Locally Advanced HER2-positive Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013