NCT00331097

ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel	35 mg/m2 intravenously on days 1, 8, and 15 every 28 days
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

Timeline

• Start date: 2003-07-01
• Primary completion: 2014-05-01
• Completion: 2014-11-01
• First posted: 2006-05-29
• Last updated: 2017-03-28

Locations

8 sites across 1 country: Italy