NCT00424203

Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ 2cm [GERICO]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.

Detailed description

OBJECTIVES: Primary * Determine the independence of older women with resected stage I, II, or III breast cancer treated with adjuvant doxorubicin hydrochloride and cyclophosphamide. Secondary * Determine the impact of this regimen on other aspects of the patient's life, utilizing the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment, the Folstein Mini-Mental State Exam, the Geriatric Depression Scale, and the Cumulative Illness Rating Scale-Geriatrics. * Determine the quality of life of patients treated with this regimen. * Determine the acceptability of this regimen in these patients. * Determine the toxicity of this regimen, in terms of cardiac issues and anemia, in these patients. * Determine recurrence-free survival, event-free survival, and overall survival of patients treated with this regimen. OUTLINE: This is a pilot, nonrandomized, multicenter study. Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients complete questionnaires at baseline and after completion of chemotherapy. Questionnaires include the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment (malnutrition), the Folstein Mini-Mental State Exam (cognitive function), the Geriatric Depression Scale (depression), the Cumulative Illness Rating Scale - Geriatrics (comorbidities), and the EORTC Quality of Life Questionnaire Core 30 (quality of life). After completion of study therapy, patients are followed every 3 months for 4 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions

• Breast Cancer
• Cognitive/Functional Effects
• Depression
• Malnutrition
• Psychosocial Effects of Cancer and Its Treatment

Interventions

Type	Name	Description
DRUG	AC regimen
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
PROCEDURE	adjuvant therapy
PROCEDURE	cognitive assessment
PROCEDURE	management of therapy complications
PROCEDURE	psychosocial assessment and care
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-01-01
• Completion: 2011-11-01
• First posted: 2007-01-18
• Last updated: 2013-09-04

Locations

17 sites across 1 country: France