Aspirus Regional Cancer Center

Cancer Clinical Trials

This is a current listing of active clinical trials at the Aspirus Regional Cancer Center. From this list you can select a specific cancer that you are interested in (for example, breast or colon cancer) and then review the clinical trials that are active at the Aspirus Regional Cancer Center for that specific disease.

Breast Cancer - Ductal Carcinoma In Situ

Trial Name: Name of Trial: 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.

Protocol ID: NSABP B-43

Eligibility:

Eligibility:
·          Pre-entry HER2 testing is required for all patients.
·          Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after completion of trastuzumab.
·          Patient must be female.
·          On histologic examination, the tumor must be ductal carcinoma in situ (DCIS).
·          The DCIS must be HER2-positive as determined by pre-entry central testing.
·          Estrogen and/or progesterone receptor status must be determined prior to randomization into the study.
·          All DCIS must have been resected by lumpectomy.
Ineligibility:
·          Invasive breast cancer
·          Contralateral breast cancer (including DCIS).
·          Whole breast irradiation administered before randomization into the study. (Partial breast irradiation is prohibited).
·          Prior history of breast cancer, including DCIS.
·          Prior anthracycline chemotherapy for any malignancy.
·          Cardiac disease that would preclude the use of the drugs included in the B-43 treatment regimens.
·          Pregnancy or lactation at the time of study entry.
·          Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Enrollment: Enrollment: · About 2000 women will take part in this study.

Benefits:

Benefits:

Taking part in this study may or may not make your health better. While doctors hope that adding trastuzumab to radiation therapy will be more useful in the treatment of HER2-positive DCIS compared to radiation therapy without trastuzumab, there is no proof of this yet. We do know that the information from this study will help doctors learn more about trastuzuamb given with radiation therapy as a treatment for HER2-positive DCIS. This information could help future breast cancer patients.

Contact:

Contact:

These clinical trial overviews are intended to provide a brief overview of the clinical trial. To help determine whether the trial is appropriate for you, the major eligibility criteria are listed above. To obtain more information on the eligibility and the treatment plan, please contact our Oncology Clinical Research Coordinator, Beth Knetter at 715-847-2353 or 1-800-283-2881, ext.72353.

Created: Jul 31, 2009

Updated: Jan 18, 2013

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