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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00424203
First received: January 16, 2007
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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]

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: November 2011
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424203

Locations
France
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
Institut Curie Hopital
Paris, France, 75248
Hopital Europeen Georges Pompidou
Paris, France, 75015
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
UNICANCER
Investigators
Study Chair: E. G. C. Brain, MD, PhD Centre Rene Huguenin
  More Information

Additional Information:
No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00424203     History of Changes
Other Study ID Numbers: CDR0000523419, FRE-FNCLCC-GERICO-06-0502, EU-20667, EUDRACT-2005-000069-20
Study First Received: January 16, 2007
Last Updated: September 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UNICANCER:
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

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Malnutrition
Nutrition Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014