Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

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: NCT00010075
Recruitment Status : Unknown
Verified June 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: fluorouracil Drug: leucovorin calcium Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:


  • Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
  • Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
  • Determine the tolerance of these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, after 3 courses, and at treatment completion.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
Study Start Date : January 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic adenocarcinoma of the breast
  • Bidimensionally measurable or evaluable disease

    • At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR
    • Serous drainage, cutaneous metastasis, osseous metastasis, etc.
  • No symptomatic cerebral metastasis
  • Hormone receptor status:

    • Not specified



  • 75 to 90


  • Female

Menopausal status:

  • Postmenopausal

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3


  • Alkaline phosphatase less than 3 times normal
  • Bilirubin less than 1.5 times normal
  • Transaminases less than 3 times normal
  • Total protein greater than 60%
  • Albumin greater than 30 g/L


  • Creatinine clearance greater than 60 mL/min


  • LVEF greater than 50% by echocardiogram or scintigraph
  • ECG normal
  • No uncontrolled angina
  • No myocardial infarction within past 6 months


  • No other medical illness or condition that would preclude study
  • No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical reasons that would preclude study


Biologic therapy:

  • Not specified


  • Prior adjuvant chemotherapy allowed
  • No prior adjuvant anthracyclines
  • No prior chemotherapy for metastatic disease

Endocrine therapy:

  • One or two prior regimens of hormonal therapy allowed for metastatic disease


  • No prior radiotherapy for metastatic disease


  • Not specified


  • No concurrent participation in another study

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): NCT00010075

Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Polyclinique De Courlancy
Metz, France, 55038
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
C.H. Senlis
Senlis, France, 60309
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Elisabeth Carola, MD C.H. Senlis Identifier: NCT00010075     History of Changes
Other Study ID Numbers: CDR0000068439
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: June 2003

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protective Agents