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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329640
Recruitment Status : Terminated
First Posted : April 6, 2011
Last Update Posted : May 21, 2014
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. INCIDENCE OF FEBRILE NEUTROPENIA [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. TUMOR SIZE [ Time Frame: From the beginning of treatment until surgery, disease progression or death ]

    Efficacy will be assessed by:

    1. Tumor measurements using MRI of the Breast
    2. Pathologic complete response
    3. Progression-free survival
    4. Overall survival

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329640

Instituto do Cancer do Estado de Sao Paulo
Sao Paulo, Brazil, 01246-000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Fundação Faculdade de Medicina

Responsible Party: Instituto do Cancer do Estado de São Paulo Identifier: NCT01329640     History of Changes
Other Study ID Numbers: NP 17/2010 TraQ-Me 01
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Metronimic chemotherapy
Locally Advanced HER2-positive Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists