RANDOMIZED STUDY OF COADYUVANT CHEMOTHERAPY WITH STANDARD REGIMES OF CYCLOPHOSPHAMIDE, METHOTREXATE AND FLUORURACILO - (CMF) OR DOXORUBICINE AND CICLOFOSFAMIDA - (AC) VERSUS CAPECITABINE IN WOMEN 65 YEARS OF AGE OR MORE POSITIVE OR NEGATIVE NODULES WITH HIGH-RISK BREAST CANCER.
Not Applicable
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-100-03
- Lead Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with operable, histologically confirmad adenocarcinoma of the female breast.
STNM Stage: T1-3, N1. MO or T2, NO, MO if a primary lesion > 3 cm.
or T3. NO. MO
Age 65 years or older
Performance status 0-2 (Common Toxicity Criteria).
Exclusion Criteria
N.A
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Physical symptoms; physical, cognitive, social, functional role and emotional state.<br>Measure:EVALUATION OF QUALITY OF LIFE<br>Timepoints:2 year<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Influence of other variables, sociodemographic, medical and psychosocial in the adjustment of elderly patients, and overall quality of life during and after adjuvant chemotherapy.<br>Measure:Assessment of quality of life<br><br>Timepoints:2 year<br>