Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Criteria

  1. Patients with operable, histologically confirmed adenocarcinoma of the female breast.
  2. TNM Stage per AJCC Cancer Staging Manual 6th edition:
    1. T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0
    2. 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.
    1. 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:
    1. Surgical resection -
      1. 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.
      2. 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.
      3. 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.
      4. 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.
    2. No prior chemotherapy for this malignancy.
    3. Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.
    4. 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:
    1. Granulocytes > 1,500/µl
    2. Platelet count ≥100,000/µl
    3. Calculated Creatinine Clearance > 30 mL/min
    4. Total bilirubin ≤ ULN

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

  • Muss HB, Berry DA, Cirrincione CT et al.: Adjuvant chemotherapy in older women with early-stage breast cancer. N. Engl. J. Med. 360, 2055-2065 (2009). To date, only two prospective trials evaluating adjuvant therapy for breast cancer in older adults have been published. The second and more recent trial, Cancer and Leukemia Group B (CALGB) 49907, provides substantial evidence supporting the use of standard adjuvant chemotherapy regimens (doxorubicin-cyclophosphamide or cyclophosphamide-methotrexate-5-fluorouracil) as opposed to simplified oral regimens (capecitabine). In this trial, both the risk of relapse (hazard ratio: 2.09; 95% CI: 1.38-3.17; p < 0.001) and the risk of death (hazard ratio: 1.85; 95% CI: 1.11-3.08; p = 0.02) were significantly higher with capecitabine compared with standard chemotherapy. The current review explores both the implications and potential caveats of this innovative trial. CALGB 49907 represents a paradigm for further studies of adjuvant cancer therapy in older adults. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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