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Breast CancerPhase 2NCT00424203

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

A Phase 2 study testing AC regimen, cyclophosphamide and doxorubicin hydrochloride in people with Breast Cancer and Cognitive/Functional Effects, run by UNICANCER at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older, women only
What is being tested?
AC regimen, cyclophosphamide and doxorubicin hydrochloride
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
17 sitesFrance
Study dates
Jan 2006to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Centre Paul Papin

    Angers, 49036

  • Institut Sainte Catherine

    Avignon, 84082

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Perpetuel Secours

    Levallois-Perret, 92309

  • Centre Leon Berard

    Lyon, 69373

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Institut Curie Hopital

    Paris, 75248

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • C.H. Senlis

    Senlis, 60309

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

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]

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.

Read the 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.

Being tested
AC regimen, cyclophosphamide, doxorubicin hydrochloride, adjuvant therapy, cognitive assessment
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
Medical subject headings
Breast Neoplasms, Depression, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC regimenDrug

  • cyclophosphamideDrug

  • doxorubicin hydrochlorideDrug

  • adjuvant therapyProcedure or surgery

  • cognitive assessmentProcedure or surgery

  • management of therapy complicationsProcedure or surgery

  • psychosocial assessment and careProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

Study groups in NCT00424203
Study groupRoleWhat they receive
Myocet, EndoxanExperimentalNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (1)

  1. Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2008
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424203
Sponsor's protocol ID
CDR0000523419
Other IDs
FRE-FNCLCC-GERICO-06-0502, EU-20667, EUDRACT-2005-000069-20
Status last verified
Sep 2013
First submitted
16 Jan 2007
Last updated
4 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AC regimen, cyclophosphamide and doxorubicin hydrochloride in people with Breast Cancer and Cognitive/Functional Effects, run by UNICANCER at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.

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