Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
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.
Psychosocial Effects of Cancer and Its Treatment
Drug: AC regimen
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Procedure: cognitive assessment
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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]|
- Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Study Completion Date:||November 2011|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
|Experimental: Myocet, Endoxan||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|
- Determine the independence of older women with resected stage I, II, or III breast cancer treated with adjuvant doxorubicin hydrochloride and cyclophosphamide.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424203
|Centre Paul Papin|
|Angers, France, 49036|
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Bordeaux, France, 33076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Hopital Perpetuel Secours|
|Levallois, France, 92309|
|Centre Leon Berard|
|Lyon, France, 69373|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Institut Curie Hopital|
|Paris, France, 75248|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Senlis, France, 60309|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Study Chair:||E. G. C. Brain, MD, PhD||Centre Rene Huguenin|