This trial is active, not recruiting.

Condition breast cancer
Treatments docetaxel, cyclophosphamide, methotrexate, 5-fluorouracil
Phase phase 3
Sponsor National Cancer Institute, Naples
Start date July 2003
End date May 2014
Trial size 300 participants
Trial identifier NCT00331097, ELDA


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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
Weekly docetaxel
35 mg/m2 intravenously on days 1, 8, and 15 every 28 days

Primary Outcomes

disease free survival
time frame: at 5 years

Secondary Outcomes

time frame: weekly
time frame: every 3 weeks
quality of life
time frame: baseline and every 3 weeks during therapy
overall survival
time frame: at 5 years

Eligibility Criteria

Female participants from 65 years up to 80 years old.

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

Additional Information

Official title Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF
Principal investigator Andrea De Matteis, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.