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| Sponsored by: |
Medical Research Council |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002953 |
Purpose
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: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer |
| Estimated Enrollment: | 704 |
| Study Start Date: | December 1996 |
OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel.
Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female Performance status:
Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases) Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of cardiac disease including myocardial infarction, cardiac failure and angina Other: Not pregnant No prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| South Africa | |
| Groote Schuur Hospital, Cape Town | |
| Cape Town, South Africa, 7925 | |
| United Kingdom | |
| Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
| United Kingdom, England | |
| Bristol Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Bristol Royal Hospital for Sick Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, W1N 8AA | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Norfolk & Norwich Hospital | |
| Norwich, England, United Kingdom, NR1 3SR | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 7LJ | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Southend General Hospital | |
| Westcliff-On-Sea, England, United Kingdom | |
| University Birmingham | |
| Birmingham, England, United Kingdom, B15 2TT | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| United Kingdom, Scotland | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| Study Chair: | James Carmichael, MD, PhD | Nottingham City Hospital NHS Trust |
More Information
| Study ID Numbers: | CDR0000065426, MRC-UKCCCR-AB01, EU-97002 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002953 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer |
|
Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Cyclophosphamide Epirubicin Immunosuppressive Agents Anti-Bacterial Agents |
Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Antimitotic Agents Cyclophosphamide Antibiotics, Antineoplastic Epirubicin Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
