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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


Who can Participate?


65 and older



1. Patients with operable, histologically confirmed adenocarcinoma of the female breast.

2. TNM Stage per AJCC Cancer Staging Manual 6th edition:

- T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0

- Patients with bilateral, synchronous breast cancer are eligible as long as one
primary tumor meets the criteria above.

3. Patients with HER2/neu positive, negative or unknown disease are eligible for this

Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or
demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as
outlined in the protocol.

4. Age 65 years or older

5. Performance status 0-2 (Common Toxicity Criteria).

6. Prior treatment:

- Surgical resection -

- All tumor should be removed by either a modified radical mastectomy or a
lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within
84 days of axillary dissection if patient's most extensive breast surgery
was a breast sparing procedure.

- Node dissection: Axillary node dissection is not required. Management of
the axilla is at the discretion of the treating physician. There is no
restriction on eligibility based on the number of nodes removed.

- Mastectomy: There should be no evidence of gross or microscopic invasive
tumor at the surgical resection margins noted in the final surgery or
pathology reports for patients who have had a modified radical mastectomy.
Patients with close margins (tumor < 1 mm from margin) are eligible.

- Segmental mastectomy (lumpectomy): Although clear margins are preferable,
DCIS or LCIS at the surgical resection margin will not render a patient who
has undergone a segmental mastectomy ineligible for this study. Invasive
tumor at the final resection margin will render a patient ineligible.

- No prior chemotherapy for this malignancy.

- Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine
dehydrogenase (DPD) deficiency are not eligible to participate.

- Patients may receive up to four weeks of tamoxifen therapy for this malignancy
and still be eligible for study entry. Patients who received tamoxifen or
raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention
Trial) or for other indications (including previous breast cancer) are eligible.
Tamoxifen or raloxifene therapy should be discontinued before the patient is
enrolled on this study.

7. Required Initial Laboratory Data:

- Granulocytes > 1,500/µl

- Platelet count ≥100,000/µl

- Calculated Creatinine Clearance > 30 mL/min

- Total bilirubin ≤ ULN

Gender: Female
Steward Physician(s)
  • Hyman B. Muss, MD
  • Antonio C. Wolff, MD
  • Julie R. Gralow, MD
  • Debjani Grenier, MD
  • Norwood Hospital - Completed
Trial Interventions
  • 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: Alliance for Clinical Trials in Oncology
Phase: Phase 3
Trial ID: NCT00024102
Volunteers:  Not Accepting Healthy Volunteers

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