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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424203
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cognitive/Functional Effects Depression Malnutrition Psychosocial Effects of Cancer and Its Treatment 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 Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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]
Study Start Date : January 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • At least 60 days since prior therapeutic surgery
  • At least 4 weeks since prior investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424203

Centre Paul Papin
Angers, France, 49036
Institut Sainte Catherine
Avignon, France, 84082
Institut Bergonie
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
Hopital Europeen Georges Pompidou
Paris, France, 75015
Institut Curie Hopital
Paris, France, 75248
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
C.H. Senlis
Senlis, France, 60309
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Study Chair: E. G. C. Brain, MD, PhD Institut Curie

Responsible Party: UNICANCER Identifier: NCT00424203     History of Changes
Other Study ID Numbers: CDR0000523419
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by UNICANCER:
cognitive/functional effects
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Behavioral Symptoms
Nutrition Disorders
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors