Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Standard Treatment; capecitabine
Intervention description: Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 & 8 and 5-FU 600 mg/sq m IV push d 1 & 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles; 2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles
Intervention MeSH terms: Doxorubicin; Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 633.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      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.
    

Eligibility criteria:

        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
             trial.

             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