A Study of Combination Chemotherapy for Treating Women with Stage II or Stage IIIA Breast Cancer that has Spread to the Lymph Nodes


About this study

The purpose of this study is to compare the effectiveness of two different combinations of chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective 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.

Eligibility Criteria

  • Disease characteristics
    • Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast
    • Histologically involved lymph nodes (T1, 2, or 3; N1 or 2, M0) or high-risk node-negative disease (T2 or 3, N0)
      • Primary tumor at least 2.1 cm in diameter for node-negative disease
      • Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above
    • Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis
    • Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection)
      • Additional axillary nodes may be obtained provided they are also negative for metastasis
    • Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy
      • Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed)
    • Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed
    • Hormone receptor status
      • Estrogen receptor status positive, negative, or unknown
  • 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/mm^3
      • Platelet count at least 100,000/mm^3
    • Hepatic
      • Bilirubin no greater than 1.5 mg/dL
      • SGOT no greater than 2 times upper limit of normal 
    • Renal
      • Creatinine no greater than 1.5 mg/dL
    • Cardiovascular
      • No history of myocardial infarction
      • No congestive heart failure
      • No significant ischemic or valvular heart disease
    • Other
      • No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
      • No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
      • Not pregnant or nursing
      • Fertile patients must use effective barrier contraception
  • Prior concurrent therapy
    • Biologic therapy not specified
    • Chemotherapy 
      • No prior chemotherapy for breast cancer
      • No concurrent tamoxifen or other SERMs
      • Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed
        • Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed
    • Endocrine therapy not specified
    • Radiotherapy
      • No prior radiotherapy for this malignancy
      • At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ
    • Surgery:
      • See Disease Characteristics
      • Less than 84 days since prior surgical procedure to adequately treat primary tumor

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

Eau Claire, Wis.

Mayo Clinic principal investigator

Sakti Chakrabarti, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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