Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II 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: NCT00004237
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 6, 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. Combining more than one drug may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: vinorelbine tartrate Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the efficacy of vinorelbine/epirubicin and vinorelbine/mitoxantrone in terms of clinical objective tumor response, clinical complete remission, and pathological complete remission in women with early stage breast cancer.
  • Compare the efficacy of these 2 new regimens with an established regimen of cyclophosphamide/doxorubicin in a randomly selected control group of patients.
  • Compare the toxicity and side effects of these 2 new regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and age (under 50 vs 50 and over). Patients are randomized to one of three treatment arms.

  • Arm I: Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1.
  • Arm II: Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1.
  • Arm III: Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or disease progression. All patients except those who are under 50 and whose tumors are estrogen receptor negative receive oral adjuvant tamoxifen daily in addition to chemotherapy.

All patients are offered surgery following completion of chemotherapy. Radiotherapy begins within 4 weeks of completion of chemotherapy or surgery, whichever is the immediately preceding treatment.

Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 62-125 patients will be accrued for this study within 12-18 months.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer
Study Start Date : October 1998
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary breast cancer that is potentially operable

    • Synchronous bilateral tumors eligible
    • At least 3 cm in maximum diameter

      • Tumors at least 2 cm eligible provided primary chemotherapy is deemed appropriate and radical surgery would otherwise be required
  • No evidence of metastatic disease
  • No prior breast cancer
  • Hormone receptor status:

    • Not specified



  • 18 to 70


  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 150,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Transaminases no greater than 1.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No uncontrolled angina pectoris
  • No heart failure
  • No clinically significant uncontrolled cardiac arrhythmias
  • LVEF at least 50%


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No medical or psychiatric condition that impairs ability to cope physically or psychologically with the chemotherapy regimen
  • No other serious uncontrolled medical condition
  • No other prior malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix


  • See Disease Characteristics

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): NCT00004237

United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Study Chair: Ian E. Smith, MD Royal Marsden NHS Foundation Trust Identifier: NCT00004237     History of Changes
Other Study ID Numbers: CDR0000067481
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: May 2005

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Sensory System Agents
Peripheral Nervous System Agents