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

Breast Cancer Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424203
• Other study ID #: CDR0000523419
• Secondary ID: FRE-FNCLCC-GERIC
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2007
• Last updated: September 2, 2013
• Start date: January 2006
• Est. completion date: November 2011

Study information

• Verified date: September 2013
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognitive/Functional Effects
• Depression
• Malnutrition
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Drug:
• AC regimen

• cyclophosphamide

• doxorubicin hydrochloride

Procedure:
• adjuvant therapy

• cognitive assessment

• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Institut Sainte Catherine	Avignon
France	Institut Bergonie	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Hopital Perpetuel Secours	Levallois
France	Centre Leon Berard	Lyon
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional Rene Gauducheau	Nantes-Saint Herblain
France	Hopital Europeen Georges Pompidou	Paris
France	Institut Curie Hopital	Paris
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	C.H. Senlis	Senlis
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy		12 weeks	No
Secondary	Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)		3 years	Yes