ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: cyclophosphamide
* Drug: methotrexate
* Drug: 5-fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Standard chemotherapy with CMF | Drug: cyclophosphamide<br>* 600 mg/m2 intravenously days 1, 8 every 28 days<br>Drug: methotrexate<br>* 40 mg/m2 intravenously days 1 and 8 every 28 days<br>Drug: 5-fluorouracil<br>* 600 mg/m2 intravenously days 1 and 8 every 28 days<br>|
| Experimental: B<br>Weekly docetaxel | Drug: docetaxel<br>* 35 mg/m2 intravenously on days 1, 8, and 15 every 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | weekly | 
| compliance |  | every 3 weeks | 
| quality of life |  | baseline and every 3 weeks during therapy | 
| overall survival |  | at 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, adjuvant therapy, intermediate risk, high risk