ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

National Cancer Institute, Naples

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: docetaxel

Drug: cyclophosphamide

Drug: 5-fluorouracil

Drug: methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT00331097

ELDA

Details and patient eligibility

About

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).

Full 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.

Enrollment

300 patients

Sex

Female

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

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