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

NCT00424203 | Completed Phase 2

• 4 other identifiers: CDR0000523419FRE-FNCLCC-GERICO-06-0502EU-20667EUDRACT-2005-000069-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Keywords

cognitive/functional effects; depression; malnutrition; psychosocial effects of cancer and its treatment; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)

  3 years

Study Arms (1)

Myocet, Endoxan

EXPERIMENTAL

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

Interventions

AC regimen DRUG

Myocet, Endoxan

cyclophosphamide DRUG

Myocet, Endoxan

doxorubicin hydrochloride DRUG

Myocet, Endoxan

adjuvant therapy PROCEDURE

Myocet, Endoxan

cognitive assessment PROCEDURE

Myocet, Endoxan

management of therapy complications PROCEDURE

Myocet, Endoxan

psychosocial assessment and care PROCEDURE

Myocet, Endoxan

quality-of-life assessment PROCEDURE

Myocet, Endoxan

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the breast * Stage I, II or III disease * pN+ or pN0 with grade III disease (tumor size ≥ 2 cm) * No metastatic disease * Must have undergone prior conservative or radical surgery that included axillary lymph node or sentinel node dissection * No residual tumor * Negative margins * Hormone receptor status: * Estrogen receptor and progesterone receptor negative PATIENT CHARACTERISTICS: * Female * Postmenopausal * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 10 g/dL * Alkaline phosphatase \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 1.25 times ULN * AST and ALT \< 2.5 times ULN * Creatinine clearance ≥ 40 mL/min * No contraindication to receiving anthracyclines or alkalizing agents * FEV normal * Activities of Daily Living (ADL) score ≥ 5 * No decrease of ≥ 1 point within the past 3 months * None of the following at baseline: * Cognitive deficiency (Folstein Mini-Mental State \< 25) * Severe depression (Geriatric Depression Scale ≥ 20) * Severe malnutrition (Mini-Nutritional Assessment ≤ 17) * No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics grade 3-4), including any of the following: * Cardiac insufficiency * Unstable angina * Myocardiopathy * Myocardial infarction within the past year * Uncontrolled hypertension * Uncontrolled high-risk arrhythmia * Severe medullary insufficiency * Neurological or psychological condition that would preclude study consent * Uncontrolled or active infection * Severe urinary tract infection * Preexisting hematuria * Active ulcer * Uncontrolled diabetes * No other cancer within the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix * No familial, geographical, social, or psychological condition that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 60 days since prior therapeutic surgery * At least 4 weeks since prior investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (17)

Centre Paul Papin

Angers, 49036, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92309, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Depression; Malnutrition

Interventions

Cyclophosphamide; Doxorubicin; Chemotherapy, Adjuvant; Mental Status and Dementia Tests; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Combined Modality Therapy; Therapeutics; Drug Therapy; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• E. G. C. Brain, MD, PhD

  Institut Curie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: November 1, 2011
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

FR (17)