- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004237
Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
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
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- 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
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
England
-
Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Transaminases no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No uncontrolled angina pectoris
- No heart failure
- No clinically significant uncontrolled cardiac arrhythmias
- LVEF at least 50%
Other:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Ian E. Smith, MD, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Epirubicin
- Doxorubicin
- Liposomal doxorubicin
- Vinorelbine
- Mitoxantrone
Other Study ID Numbers
- CDR0000067481
- RMNHS-TOPIC2
- EU-99037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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