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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 1771-99
    • Jacksonville, Florida: 1771-99
    • Rochester, Minnesota: 1771-99
    NCT ID: NCT00004125
    Sponsor Protocol Number: E1199

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

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

Rochester, Minn.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

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CLS-20154140

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