- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00331097
ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment
Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- standard adjuvant chemotherapy with CMF (cyclophosphamide, methotrexate, and 5-fluorouracil given intravenously on days 1 and 8 of each cycle)
- experimental adjuvant chemotherapy with weekly docetaxel (given intravenously on days 1,8, and 15 of each cycle)
In both treatment strategies:
- 4 cycles of chemotherapy will administered for patients at least 10% positive for ER or PgR, and 6 cycles will administered for patients expressing < 10% ER or PgR
- patients with any positive expression of ER or PgR will receive adjuvant hormonal therapy with tamoxifen (20mg/day for 5 years) after concluding chemotherapy
- adjuvant radiation therapy will be given to patients who are candidates at the conclusion of chemotherapy and within 6 months of surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Napoli, Italy, 80131
- Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
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Napoli, Italy
- Università Federico II, Cattedra di Oncologia Medica
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Napoli, Italy, 80131
- Azienda Ospedaliera Cardarelli
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Treviglio, Italy
- Az. Osp. Treviglio - Caravaggio
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Vallo della Lucania, Italy
- Ospedale S. Luca ASL SA 3
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AV
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Monteforte Irpino, AV, Italy
- Azienda Sanitaria S. Giuseppe Moscati
-
-
BN
-
Benevento, BN, Italy
- Azienda Ospedaliera G. Rummo
-
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PG
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Sant'Andrea delle Frate, PG, Italy
- Policlinico Monteluce
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed invasive unilateral breast cancer
- Age > 65 and < 80 years
- Intermediate-high risk of recurrence according to St. Gallen criteria: ER negative and PgR negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)
Exclusion Criteria:
- Performance status >1
- Distant metastasis
- Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
- Previous breast cancer treatment
- Neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
- Creatinine > 1.25 the upper normal limit
- GOT and-or GPT and/or bilirubin > 1.25 the upper normal limit
- Concomitant conditions that contraindicate the use of the drugs in the protocol
- Incapacity or refusal to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: A
Standard chemotherapy with CMF
|
600 mg/m2 intravenously days 1, 8 every 28 days
40 mg/m2 intravenously days 1 and 8 every 28 days
600 mg/m2 intravenously days 1 and 8 every 28 days
|
EXPERIMENTAL: B
Weekly docetaxel
|
35 mg/m2 intravenously on days 1, 8, and 15 every 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease free survival
Time Frame: at 5 years
|
at 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicity
Time Frame: weekly
|
weekly
|
compliance
Time Frame: every 3 weeks
|
every 3 weeks
|
quality of life
Time Frame: baseline and every 3 weeks during therapy
|
baseline and every 3 weeks during therapy
|
overall survival
Time Frame: at 5 years
|
at 5 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Nuzzo F, Morabito A, De Maio E, Di Rella F, Gravina A, Labonia V, Landi G, Pacilio C, Piccirillo MC, Rossi E, D'Aiuto G, Thomas R, Gori S, Colozza M, De Placido S, Lauria R, Signoriello G, Gallo C, Perrone F, de Matteis A. Weekly docetaxel versus CMF as adjuvant chemotherapy for elderly breast cancer patients: safety data from the multicentre phase 3 randomised ELDA trial. Crit Rev Oncol Hematol. 2008 May;66(2):171-80. doi: 10.1016/j.critrevonc.2007.10.006. Epub 2007 Dec 21.
- Perrone F, Nuzzo F, Di Rella F, Gravina A, Iodice G, Labonia V, Landi G, Pacilio C, Rossi E, De Laurentiis M, D'Aiuto M, Botti G, Forestieri V, Lauria R, De Placido S, Tinessa V, Daniele B, Gori S, Colantuoni G, Barni S, Riccardi F, De Maio E, Montanino A, Morabito A, Daniele G, Di Maio M, Piccirillo MC, Signoriello S, Gallo C, de Matteis A. Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial. Ann Oncol. 2015 Apr;26(4):675-682. doi: 10.1093/annonc/mdu564. Epub 2014 Dec 8.
- Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015 Mar 10;33(8):910-5. doi: 10.1200/JCO.2014.57.9334. Epub 2015 Jan 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
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
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Docetaxel
- Cyclophosphamide
- Fluorouracil
- Methotrexate
Other Study ID Numbers
- ELDA
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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