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PSOC

Herceptin + Radiation Therapy for HER2-Positive Resected by Lumpectomy (NSABP B-43)
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Status Conditions Phase Study ID
Recruiting Breast Cancer Phase III NSABP B-43
NCT00769379
Summary

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.


Investigator
Tanya A. Wahl
Location    
Fred Hutchinson Cancer Research Center 800-804-8824  
Olympic Medical Center, Sequim WA 360-683-9895  
Overlake Hospital Medical Center, Bellevue WA 425-688-5407  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS)

    • Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
  • HER2 receptor-positive as determined by central testing
  • Must have undergone resection by lumpectomy and meets the following criteria:

    • Margins of the resected specimen must be histologically free of DCIS (re-excision to obtain clear margins allowed)
    • No more than 120 days since the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins)
  • None of the following allowed:

    • Patients who require mastectomy
    • Invasive (including microinvasion staged as T1mic) breast cancer (DCIS "suspicious" for microinvasion, but not confirmed, allowed)
    • Nodal staging of pN1 (including pN1mi) (axillary staging not required)
    • DCIS present in more than one quadrant (multicentric)
    • Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign
    • Contralateral breast cancer (including DCIS)
    • History of breast cancer, including DCIS (history of LCIS allowed)
  • Hormone receptor status:

    • Estrogen receptor and/or progesterone receptor-positive or -negative
  • Must submit tumor block for correlative studies
Last Updated
March 14, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at the Puget Sound Oncology Consortium site.
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.