Combination Chemotherapy Compared With Mitoxantrone in Treating Older Patients With Advanced 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: NCT00002498
Recruitment Status : Unknown
Verified May 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 23, 2004
Last Update Posted : December 18, 2013
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. Giving drugs in different combinations may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide, methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:

OBJECTIVES: I. Determine the response rate and duration of response of elderly patients with advanced breast cancer treated with first-line chemotherapy with mitigated "classical" CMF (cyclophosphamide/methotrexate/fluorouracil) vs. mitoxantrone (DHAD). II. Define the morbidity of CMF and DHAD in elderly patients. III. Determine quality of life in these patients.

OUTLINE: This is a randomized study. Patients are stratified by participating institution. The first group receives oral cyclophosphamide on days 1 through 14 and intravenous methotrexate and fluorouracil on days 1 and 8. Courses repeat every 4 weeks for a maximum of 6 courses. The second group receives intravenous mitoxantrone every 3 weeks for a maximum of 8 courses. Concomitant therapy with hepatotoxic or nephrotoxic drugs (e.g., NSAIDs) or corticosteroids (even as antiemetics) is not permitted in either group. Radiotherapy is allowed provided no more than 50% of the bone marrow is irradiated and at least 1 indicator lesion is unirradiated. Patients who complete therapy are followed every 3 months until disease progression.

PROJECTED ACCRUAL: 60 patients will be accrued over approximately 1 year. If extreme differences between arms exist after entry of 30 patients, accrual may be stopped early.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : July 1992

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:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven, progressive, recurrent or metastatic breast cancer in patients over 70 years of age Measurable or evaluable disease required, including: Lesions of the mediastinum, retroperitoneum, or liver at least 3 cm in diameter on CT scan or ultrasound The following are not considered measurable or evaluable: Lymphedema Hilar enlargement Pleural effusion Ascites Bone marrow infiltration Osteoblastic skeletal lesion No CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 70 Sex: Not specified Menopausal status: Postmenopausal Performance status: WHO 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 1.4 mg/dL (25 micromoles/L) Renal: Creatinine clearance (calculated) greater than 50 mL/min in patients weighing at least 45 kg and measured creatinine clearance at least 50 mL/min in patients weighing less than 45 kg Cardiovascular: No congestive heart failure No myocardial infarction within 6 months No severe arrhythmia No complete bundle branch block Other: No active uncontrolled infection No mental disorders that may preclude patient follow-up No second malignancy except: Adequately treated basal cell carcinoma of the skin Adequately treated in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced disease At least 1 year since prior adjuvant chemotherapy Endocrine therapy: At least 4 weeks since prior estrogens, androgens, and progestins Tamoxifen or aminoglutethimide allowed with no waiting period if disease progresses Recovery from prior hormonal therapy for metastatic disease required Radiotherapy: Prior radiotherapy allowed provided: Evaluable disease exists outside of treatment field No greater than 50% of bone marrow was irradiated Surgery: Not specified

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): NCT00002498

Leiden University Medical Center
Leiden, Netherlands, 2300 ZA
St. Radboud University Hospital
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Leiden University Medical Center
Study Chair: Marianne A. Nooij, MD Leiden University Medical Center Identifier: NCT00002498     History of Changes
Other Study ID Numbers: CDR0000077804
First Posted: August 23, 2004    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2000

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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Sensory System Agents
Peripheral Nervous System Agents