Clinical trial NCT00424203: Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2007-01-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy
timeFrame: 12 weeks
Secondary outcomes:
measure: Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)
timeFrame: 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Levallois
country: France
facility: Hopital Perpetuel Secours
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Nantes-Saint Herblain
country: France
facility: Centre Regional Rene Gauducheau
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Institut Curie Hopital
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Senlis
country: France
facility: C.H. Senlis
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Institut Curie
name: E. G. C. Brain, MD, PhD
role: STUDY_CHAIR
References: