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Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer (TAME-01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação Faculdade de Medicina
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01329627
First received: November 8, 2010
Last updated: June 22, 2011
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.


Condition Intervention Phase
Locally Advanced HER2-negative Breast Cancer
 Drug: Paclitaxel/doxorubicin/cyclophosphamide
 Phase 2

Study Type: Interventional
Study Design: 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 Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative 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 modified metronomic schedule (whithout GCSF) will be no higher than 10%


Secondary Outcome Measures:
  • Efficacy [ Time Frame: From the beginning of treatment until surgery, progression and death ] [ Designated as safety issue: No ]

    Efficacy will be assessed by:

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


Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel/doxorubicin/cyclophosphamide Drug: Paclitaxel/doxorubicin/cyclophosphamide

Metronomic chemotherapy as described below:

  1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by;
  2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.
Other Name: Metronomic chemotherapy
Drug: Paclitaxel/doxorubicin/cyclophosphamide

Metronomic chemotherapy as described below:

Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.

Other Name: Metronomic chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced breast cancer diagnosed by guided core biopsy
  • T > 2 cm (any N), or any T and node positive (needle biopsy is required)
  • Non-metastatic disease assessed by computed tomography and bone scintigraphy
  • Histological grade 2 and Ki67 > 15% or
  • Histological grade 3 or
  • Any triple negative (TN) or
  • Inflammatory breast cancer (IBC)
  • Normal left ventricular ejection fraction (LVEF)
  • HER2-negative disease

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 as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
  • LVEF value below institutional limits of normal
  • Predominant lobular carcinoma histology
  • Grade 1 tumors
  • Detected or suspicious distant metastasis
  • Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
  • Male sex
  • HER2-positive breast cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329627

Locations
Brazil
State of Sao Paulo Cancer Institute Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Alessandro Leal, Physician     +55-11-38932686        
Contact: Max Mano, Physician     +55-11-38932686        
Sub-Investigator: Alessandro Leal, Physician            
Principal Investigator: Max Mano, Physician            
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: NCT01329627     History of Changes
Other Study ID Numbers: TAME-01
Study First Received: November 8, 2010
Last Updated: June 22, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
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
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013