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.

Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer

Trial Name: A Phase III, Randomized Clinical Trial of Standard, Adjuvant Endocrine Therapy +/- Chemotherapy In Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer With Recurrence Score (RS) of 25 Or Less.

Protocol ID: S1007

Eligibility:

 Eligibility:

  • Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, as determined by IHC or non-amplified FISH for screening.
  • Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
  • Patients must not have inflammatory breast cancer and must not have metastatic disease.  Patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation or endocrine therapy).
  • Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation). 
  • Patients must be females 18 years of age or older.  As the Oncotype DX® Recurrence Score has not been validated in men with breast cancer; men are not eligible for this study.
  • Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration to the study.
  • Patients must not have received preventative tamoxifen or raloxifene, or have received prior therapeutic breast radiation.
  • Pregnant or nursing women are not eligible because of the risk of fetal harm.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years.

Enrollment: • About 4,000 women will take part in this study at several medical centers. We expect that about 8,800 women may be tested to see if they can take part, and that about 600 women may have already received the testing before they learn about this clinical trial.

Benefits:

Taking part in this study may or may not make your health better.  While doctors hope that the Oncotype DX® test will improve the effectiveness of cancer treatment decision-making compared to the usual methods of deciding treatment, there is no proof of this yet.  We do know that the information from this study will help doctors learn more about the use of the Oncotype DX® test in relation to understanding the risk of breast cancer recurrence.  This information could help future cancer patients.

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 Aspirus Regional Cancer Center Oncology Clinical Research Coordinator, Beth Knetter at 715-847-2353 or 1-800-283-2881, ext.72353, or Langlade Cancer Center Research Nurse Debra Witman @ 715-623-9587.

Created: Aug 17, 2011

Updated: May 21, 2014

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