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A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

Phase 3
65 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer


- Compare the effectiveness of adjuvant chemotherapy comprising standard
cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and
cyclophosphamide (AC) vs oral capecitabine, in terms of disease-free and overall
survival, in elderly women with operable adenocarcinoma of the breast.

- Compare the quality of life and physical functioning of patients treated with these

- Compare the toxicity of these regimens in these patients.

- Evaluate the adherence of older patients to an oral chemotherapy regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(65 to 69 vs 70 to 80 vs over 80), performance status (0-1 vs 2), and HER2 status (positive
vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients with insufficient left ventricular ejection fraction (LVEF) are
assigned to group A. Patients with normal LVEF are assigned to group A or B based on
physician/patient choice.

- Group A (CMF): Patients receive oral cyclophosphamide (CTX) daily on days 1-14 and
methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4
weeks for 6 courses in the absence of disease progression or unacceptable

- Group B (AC): Patients receive doxorubicin IV and CTX IV on day 1. Treatment
repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats
every 3 weeks for 6 courses in the absence of disease progression or unacceptable

Beginning within 12 weeks after treatment in arm I or II, patients with estrogen or
progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor
daily for 5 years.

Beginning 4-6 weeks after treatment in arm I or II, eligible patients who previously
underwent breast conservation surgery undergo radiotherapy.

Quality of life is assessed at baseline; at 6 weeks (group B), 9 weeks (arm II), or 12 weeks
(group A); and then at 1, 12, 18, and 24 months after study.

Drug adherence is assessed at 9 weeks during study (arm II).

Patients are followed at 1 month, every 6 months for 2 years, and then annually for 15

PROJECTED ACCRUAL: A total of 600-1,800 patients (300-900 per treatment arm) will be accrued
for this study within 2-6 years.

Inclusion Criteria


- Histologically proven operable adenocarcinoma of the breast*

- Stage I-IIIC disease

- T1-4 (tumor size ≥ 1 cm), N0, M0 OR

- T1-4, N1-3, M0 NOTE: *Bilateral, synchronous breast cancer allowed provided
1 primary tumor meets the staging criteria

- Must have undergone 1 of the following within the past 12 weeks:

- Modified radical mastectomy

- No evidence of gross or microscopic invasive tumor at the surgical
resection margins

- Close margins (tumor less than 1 mm from margin) allowed

- Lumpectomy (clear margins preferred)

- Ductal carcinoma in situ or lobular carcinoma in situ at the surgical
resection margin allowed

- No invasive tumor at the final resection margin

- Any number of previously excised nodes allowed

- Axillary node dissection not required

- HER2/neu positive, negative, or unknown

- Patients with HER2 positive tumors by immunohistochemistry 3+ staining or that
demonstrate gene amplification by fluorescence in situ hybridization are
eligible to receive trastuzumab (Herceptin) on study

- Hormone receptor status:

- Not specified



- 65 and over


- Female

Menopausal status:

- Postmenopausal

Performance status:

- 0-2

Life expectancy:

- More than 5 years


- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than upper limit of normal


- Creatinine clearance at least 30 mL/min


- No uncontrolled cardiac disease that would preclude study entry

- Left ventricular ejection fraction at least lower limit of normal (arm I, group B


- HIV negative

- No other concurrent active malignancy except nonmelanoma skin cancer

- Disease considered not currently active if completely treated with less than a
30% risk of relapse

- No psychiatric illness that would preclude informed consent

- No other medical condition (e.g., uncontrolled infection) that would preclude study

- No hypersensitivity to fluorouracil

- No known dihydropyrimidine dehydrogenase deficiency


Biologic therapy:

- Not specified


- No prior chemotherapy for breast cancer

- No other concurrent chemotherapy

Endocrine therapy:

- Up to 4 weeks of prior tamoxifen for current breast cancer allowed

- Prior tamoxifen or raloxifene for chemoprevention (e.g., breast cancer prevention
study) or other indications (including prior breast cancer) allowed but must be
discontinued before study entry

- No concurrent hormonal therapy except steroids for adrenal failure, hormones for
non-disease related conditions (e.g., insulin for diabetes), or intermittent
dexamethasone as an antiemetic


- Not specified


- See Disease Characteristics


- No concurrent dexrazoxane

- No concurrent bisphosphonates except for treatment of osteoporosis

Type of Study:


Study Design:

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

Outcome Measure:

Relapse-free Survival Rates at 2.4 Years

Outcome Description:

Percentage of participants who were alive and relapse-free at time of analysis were counted as "Alive without relapse" at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as "relapse, first occurrence". These rates were estimated using the Kaplan Meier method

Outcome Time Frame:

randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)

Safety Issue:


Principal Investigator

Hyman B. Muss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fletcher Allen Health Care - University Health Center Campus


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



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