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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-100-03
Enrollment
Unknown
Registered
2004-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

CAPECITABINA 2000 mg / m2 po x 14 days 7 days of rest cycle every 21 days for a total of 6 cycles.
Arm A Type of group
ADRIAMYCIN 60mg / m2 IV day 1 Cyclophosphamide 600 mg / m2 IV day 1 Every 21 days for 4 cycles. CICLOFOSFAMIDA 100 mg / m2 po / day. Day 1 -> 14 Metrotexate 40 mg / m2 mg IV day 1 and 8 Fluoruracil 600 mg / m2 IV day 1 and 8 every 28 days for 6 cycles. Group name:Arm B Type of group

Sponsors

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: N.A

Design outcomes

Primary

MeasureTime frame
Outcome name:Physical symptoms; physical, cognitive, social, functional role and emotional state. Measure:EVALUATION OF QUALITY OF LIFE Timepoints:2 year—

Secondary

MeasureTime frame
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. Measure:Assessment of quality of life Timepoints:2 year—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)