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

This study has been terminated.
Sponsor:
Collaborator:
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01329640
First received: November 8, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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:


Further study details as provided by Instituto do Cancer do Estado de São 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


Enrollment: 9
Study Start Date: September 2010
Study Completion Date: September 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Instituto do Cancer do Estado de São Paulo
Fundação Faculdade de Medicina
  More Information

No publications provided

Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01329640     History of Changes
Other Study ID Numbers: NP 17/2010 TraQ-Me 01
Study First Received: November 8, 2010
Last Updated: May 20, 2014
Health Authority: Brazil: National Comittee of Ethics in Research

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
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Cyclophosphamide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 16, 2014