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

Phase 3
65 Years
80 Years
Open (Enrolling)
Breast Cancer

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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

- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Time Frame:

at 5 years

Safety Issue:


Principal Investigator

Andrea De Matteis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Medical Oncology C


Italy: Ethics Committee

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • elderly
  • adjuvant therapy
  • intermediate risk
  • high risk
  • Breast Neoplasms