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SCCA Breast Cancer Clinical Trials

Phase III Paclitaxel + Trastuzumab/Lapatinib (CTSU C40601)
Randomized Phase III Trial of Paclitaxel Combined With Trastuzumab (Herceptin), Lapatinib (Tykerb), or Both as Neoadjuvant Treatment of Her2-Positive Primary Breast Cancer
Status Conditions Phase Study ID
Recruiting Breast Cancer Phase III CTSU C40601
NCT00770809
Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel together with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying paclitaxel to see how well it works when given together with trastuzumab and/or lapatinib in treating patients with stage II or stage III breast cancer that can be removed by surgery.


Investigator
Location    
Seattle Cancer Care Alliance 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed invasive breast cancer by core needle or incisional biopsy

    • Clinical stage II or III disease
    • Resectable disease
  • HER2-positive tumor, defined as 3+ overexpression by IHC or gene amplification by FISH with a ratio of ≥ 2 on invasive tumor
  • Measurable disease, defined as target lesion in the breast ≥ 1 cm by physical examination or radiographic measurement

    • No axillary disease only
  • Multicentric or bilateral disease allowed provided the target lesion meets eligibility criteria
  • Planning to undergo surgical resection after neoadjuvant therapy
  • No inflammatory breast cancer
  • No metastatic disease
  • Concurrent enrollment in CALGB-150702 required
  • Hormone receptor status known

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG (Zubrod) performance status 0-1
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception during and for ≥ 2 months after completion of study treatment
  • Cardiac ejection fraction ≥ 50% by echocardiogram or MUGA scan
  • Willing to undergo pretreatment biopsies and submit archival tissue obtained at the time of surgery

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy, hormonal therapy, biologic therapy, or radiotherapy for the treatment of breast cancer
  • No other concurrent chemotherapy or hormonal therapy, except for the following:

    • Steroids for adrenal failure
    • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic
  • No concurrent pegfilgrastim
Last Updated
April 05, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.