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

Unicancer

Status and phase: Completed; Phase 2

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

Treatments: Drug: doxorubicin hydrochloride; Procedure: psychosocial assessment and care; Procedure: management of therapy complications; Drug: cyclophosphamide; Drug: AC regimen; Procedure: adjuvant therapy; Procedure: cognitive assessment; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT00424203

CDR0000523419

FRE-FNCLCC-GERICO-06-0502

EUDRACT-2005-000069-20

EU-20667

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Myocet, Endoxan

Experimental group

Treatment:

Procedure: adjuvant therapy

Drug: doxorubicin hydrochloride

Drug: cyclophosphamide

Procedure: psychosocial assessment and care

Procedure: cognitive assessment

Drug: AC regimen

Procedure: quality-of-life assessment

Procedure: management of therapy complications