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

Phase 2

Completed

• Conditions: Breast Cancer; Cognitive/Functional Effects; Depression; Malnutrition; Psychosocial Effects of Cancer and Its Treatment
• Interventions: 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

• Registration Number: NCT00424203
• Lead Sponsor: UNICANCER

Brief 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-18
• Primary Completion: 2008-01
• Study Completion: 2011-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-02
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocet, Endoxan	AC regimen	-
Myocet, Endoxan	adjuvant therapy	-
Myocet, Endoxan	quality-of-life assessment	-
Myocet, Endoxan	cognitive assessment	-
Myocet, Endoxan	management of therapy complications	-
Myocet, Endoxan	psychosocial assessment and care	-
Myocet, Endoxan	cyclophosphamide	-
Myocet, Endoxan	doxorubicin hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy	12 weeks

Secondary Outcome Measures

Name	Time	Method
Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)	3 years

Trial Locations

Locations (17)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Regional Rene Gauducheau; 🇫🇷 Nantes-Saint Herblain, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Centre Paul Papin; 🇫🇷 Angers, France

Institut Jean Godinot; 🇫🇷 Reims, France

Institut Curie Hopital; 🇫🇷 Paris, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Hopital Perpetuel Secours; 🇫🇷 Levallois, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

C.H. Senlis; 🇫🇷 Senlis, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Institut Bergonie; 🇫🇷 Bordeaux, France