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

Primary Purpose

Breast Cancer, Cognitive/Functional Effects, Depression

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
AC regimen
cyclophosphamide
doxorubicin hydrochloride
adjuvant therapy
cognitive assessment
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Institut Sainte Catherine
  • Institut Bergonie
  • Centre Jean Perrin
  • Hopital Perpetuel Secours
  • Centre Leon Berard
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Centre Regional Rene Gauducheau
  • Hopital Europeen Georges Pompidou
  • Institut Curie Hopital
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • C.H. Senlis
  • Institut Claudius Regaud
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myocet, Endoxan

Arm Description

Outcomes

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

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)

Full Information

First Posted
January 16, 2007
Last Updated
September 2, 2013
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00424203
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myocet, Endoxan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AC regimen
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. G. C. Brain, MD, PhD
Organizational Affiliation
Institut Curie
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Perpetuel Secours
City
Levallois
ZIP/Postal Code
92309
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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