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Comparison of 2 type of neoadjuvant chemotherpy in breast cancer

Phase 3
Conditions
Breast cancer.
Malignant neoplasm of breast
c50-c50
Registration Number
IRCT2014051117644N1
Lead Sponsor
Vice chancellor for research, Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
70
Inclusion Criteria

A) positive pathology of breast cancer; Karnofsky performance status at least: 70; locally advanced breast cancer; age< 65 Years old; normal cardiac and liver and bone marrow function; normal and acceptable cardiac evaluation in high risk patients or past medical history of cardiac problem; filling the informed consent by patient.
B) Exclusion criteria: receiving previous chemotherapy for breast cancer; clinical or pathological positive evidence of metastasis; underling disease which can’t receive chemotherapy; known contraindication for chemotherapy agent (taxan reaction); sever cardiac problem history such as heart failure, chest pain which needs medication, sever cardiac valve disease, myocardial infarction, uncontrolled blood pressure (systolic pressure above 180 mm/Hg and diastolic pressure above 100 mm/Hg); refusing treatment by patient.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical response. Timepoint: Befor treatment start and every 3 weeks for 4 cycle after treatment. Method of measurement: Caliper measurment (milimeter).;Radiologic response. Timepoint: Befor treatment and 3month after chemotherapy. Method of measurement: Sonography.;Pathologic response. Timepoint: 3 months later after chemotherapy followed by surgery. Method of measurement: Pathologic size (milimeter).
Secondary Outcome Measures
NameTimeMethod
Bone marrow suppression. Timepoint: Befor chemotherpy and every 3 weeks after chemotherapy. Method of measurement: Lab data.;Extrimity edema. Timepoint: Befor chemotherpy and every 3 weeks after chemotherapy. Method of measurement: History and physical exam.;Alopecia. Timepoint: Befor chemotherpy and every 3 weeks after chemotherapy. Method of measurement: History and exam.
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