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Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 2, 2001
Last updated: July 23, 2008
Last verified: June 2003

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 Intervention Phase
Breast Cancer Drug: fluorouracil Drug: leucovorin calcium Drug: mitoxantrone hydrochloride Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
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.


Ages Eligible for Study:   75 Years to 90 Years   (Senior)
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
  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 identifier: 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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Study Chair: Elisabeth Carola, MD C.H. Senlis
  More Information Identifier: NCT00010075     History of Changes
Other Study ID Numbers: CDR0000068439
Study First Received: February 2, 2001
Last Updated: July 23, 2008

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 processed this record on September 21, 2017