ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cyclophosphamide; Docetaxel; Fluorouracil; Methotrexate

Criteria

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