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Sponsored by: |
Royal Marsden - London |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004237 |
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 | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: vinorelbine ditartrate Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary breast cancer that is potentially operable
At least 3 cm in maximum diameter
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Royal Marsden NHS Foundation Trust - Surrey | |
Sutton, England, United Kingdom, SM2 5PT |
Study Chair: | Ian E. Smith, MD | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000067481, RMNHS-TOPIC2, EU-99037 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004237 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Skin Diseases Immunologic Factors Breast Neoplasms Vinblastine Antimitotic Agents Cyclophosphamide Epirubicin Immunosuppressive Agents Doxorubicin Anti-Bacterial Agents |
Vinorelbine Tubulin Modulators Peripheral Nervous System Agents Analgesics Mitoxantrone Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Alkylating Agents Breast Diseases Skin Diseases Mitosis Modulators |
Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Epirubicin Doxorubicin Pharmacologic Actions Neoplasms Vinorelbine Tubulin Modulators Myeloablative Agonists Peripheral Nervous System Agents Mitoxantrone Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |