Trial Information

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

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.