- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329627
Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer (TAME-01)
May 20, 2014 updated by: Instituto do Cancer do Estado de São Paulo
Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sao Paulo, Brazil, 01246-000
- State of Sao Paulo Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel/doxorubicin/cyclophosphamide
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Metronomic chemotherapy as described below:
Other Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of febrile neutropenia
Time Frame: 18 weeks
|
Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
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18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: From the beginning of treatment until surgery, progression and death
|
Efficacy will be assessed by:
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From the beginning of treatment until surgery, progression and death
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
November 8, 2010
First Submitted That Met QC Criteria
April 4, 2011
First Posted (Estimate)
April 6, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Paclitaxel
- Albumin-Bound Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- NP 50/2010 - TAME
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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