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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

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
65 and older

Gender:
Female

Eligibility

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 65 and over

Sex:

- Female

Menopausal status:

- Postmenopausal

Performance status:

- 0-2

Life expectancy:

- More than 5 years

Hematopoietic:

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

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

Hepatic:

- Bilirubin no greater than upper limit of normal

Renal:

- Creatinine clearance at least 30 mL/min

Cardiovascular:

- No uncontrolled cardiac disease that would preclude study entry

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

Other:

- 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
entry

- No hypersensitivity to fluorouracil

- No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- 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

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- No concurrent dexrazoxane

- No concurrent bisphosphonates except for treatment of osteoporosis

Gender: Female
Steward Physician(s)
  • Hyman B. Muss, MD
  • Antonio C. Wolff, MD
  • Julie R. Gralow, MD
  • Debjani Grenier, MD
Facilities
  • Norwood Hospital - Completed
Trial Interventions
Drug
  • Standard Treatment
  • capecitabine
Physician Researcher

Investigator Name:

  • Hyman B. Muss, MD
  • Antonio C. Wolff, MD
  • Julie R. Gralow, MD
  • Debjani Grenier, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00024102
Volunteers:  Not Accepting Healthy Volunteers

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