Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

Overview

About this study

RATIONALE: 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.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.

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 operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with 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 OR
  • 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
    • Endocrine therapy:
    • Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed
    • 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
    • No concurrent tamoxifen or other SERMs
  • 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

Rochester, Minn.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Jacksonville, Fla.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20154140

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