Combination Chemotherapy in Treating Women With 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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.

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.

DISEASE CHARACTERISTICS:

  • Histologically confirmed resectable adenocarcinoma of the breast
  • Histologically positive lymph nodes (1 to 3) OR Lymph node negative and high risk disease Tumor greater than 1.0 cm diameter
  • May have undergone an axillary dissection with at least 6 nodes removed and examined or a sentinel node biopsy
  • Patients who are positive by sentinel node biopsy will receive an axillary dissection
  • No locally advanced or inflammatory or metastatic breast cancer
  • Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Sex: Female
  • Menopausal status: Not specified
  • Performance status: Not specified
  • Life expectancy: Not specified
  • Hematopoietic:
    • Neutrophil count at least 1,500/mm3
    • Platelet count at least 100,000/mm3
  • Hepatic:
    • Adequate hepatic function
    • Bilirubin no greater than upper limit of normal
  • Renal: Adequate renal function
  • Cardiovascular:
    • Adequate cardiac function
    • Normal MUGA or echocardiogram
  • Other:
    • Not pregnant or nursing
    • Fertile patients must use effective barrier method contraception
    • At least 5 years since prior invasive malignancies, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • Biologic therapy: Not specified
  • Chemotherapy: No prior chemotherapy for this malignancy
  • Endocrine therapy:
    • No concurrent tamoxifen
    • Up to 4 weeks of tamoxifen treatment for this malignancy allowed
  • Radiotherapy:
    • No prior radiotherapy for this malignancy
    • Prior radiotherapy to the breast for ductal carcinoma in situ allowed
  • Surgery:
    • Tumor should be removed by either a modified radical mastectomy and/or a segmental mastectomy plus axillary lymph node dissection or sentinel node biopsy before beginning treatment on protocol
    • No greater than 84 days since last surgical procedure that constitutes or completes definitive surgical therapy (mastectomy; axillary dissection/sentinel node biopsy; or resection of primary site to obtain a negative margin)

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

Edith Perez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Edith Perez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Edith Perez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

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)

International patient clinical studies questions