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Sponsored by: |
National Cancer Institute, Naples |
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Information provided by: | National Cancer Institute, Naples |
ClinicalTrials.gov Identifier: | NCT00331097 |
The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly docetaxel).
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: docetaxel Drug: cyclophosphamide Drug: methotrexate Drug: 5-fluorouracil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF |
Estimated Enrollment: | 300 |
Study Start Date: | July 2003 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Standard chemotherapy with CMF
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Drug: cyclophosphamide
600 mg/m2 intravenously days 1, 8 every 28 days
Drug: methotrexate
40 mg/m2 intravenously days 1 and 8 every 28 days
Drug: 5-fluorouracil
600 mg/m2 intravenously days 1 and 8 every 28 days
|
B: Experimental
Weekly docetaxel
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Drug: docetaxel
35 mg/m2 intravenously on days 1, 8, and 15 every 28 days
|
Adjuvant combination chemotherapy, given after breast cancer surgery, has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or high risk for recurrence. However, since elderly patients have been underrepresented in past clinical trials, the optimal adjuvant therapy for elderly patients at risk for recurrence has not yet been defined.
Docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting. Administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer.
In this study, patients from ages 65 to 80 will be randomized to one of two treatment strategies:
In both treatment strategies:
Ages Eligible for Study: | 65 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francesco Perrone, M.D., Ph.D | +39 081 5903 ext 571 | francesco.perrone@uosc.fondazionepascale.it |
Contact: Alessandro Morabito, M.D. | +39 081 5903 ext 383 | alessandro.morabito@uosc.fondazionepascale.it |
Italy | |
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C | Recruiting |
Napoli, Italy, 80131 | |
Principal Investigator: Andrea De Matteis, M.D. | |
Università Federico II, Cattedra di Oncologia Medica | Recruiting |
Napoli, Italy | |
Principal Investigator: Angelo Raffaele Bianco, M.D. | |
Principal Investigator: Sabino De Placido, M.D. | |
Italy, BN | |
Azienda Ospedaliera G. Rummo | Recruiting |
Benevento, BN, Italy | |
Principal Investigator: Bruno Daniele, M.D. | |
Italy, PG | |
Policlinico Monteluce | Recruiting |
Sant'Andrea delle Frate, PG, Italy | |
Principal Investigator: Lucio Crinò, M.D. |
Principal Investigator: | Andrea De Matteis, M.D. | NCI Naples, Division of Medical Oncology C |
Principal Investigator: | Giuseppe D'Aiuto, M.D. | NCI Naples, Division of Surgical Oncology A |
Principal Investigator: | Francesco Perrone, M.D., Ph.D. | NCI Naples, Clinical Trials Unit |
Responsible Party: | National Cancer Institute Naples ( Francesco Perrone, Director, Clinical Trials Unit ) |
Study ID Numbers: | ELDA |
Study First Received: | May 26, 2006 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00331097 |
Health Authority: | Italy: Ethics Committee |
elderly adjuvant therapy intermediate risk high risk |
Folic Acid Docetaxel Skin Diseases Fluorouracil |
Methotrexate Breast Neoplasms Cyclophosphamide Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |