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

This study has been terminated.
(Toxicity)
Sponsor:
Collaborator:
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01329627
First received: November 8, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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:


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 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


Enrollment: 12
Study Start Date: August 2010
Study Completion Date: August 2012
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
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: NCT01329627

Locations
Brazil
State of Sao Paulo Cancer Institute
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: NCT01329627     History of Changes
Other Study ID Numbers: NP 50/2010 - TAME
Study First Received: November 8, 2010
Last Updated: May 20, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on October 21, 2014