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.

High Risk Breast Cancer

Trial Name: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer.

Protocol ID: NSABP B-47

Eligibility:

  • The patient must be female
  • The patient must be 18 yrs. of age or older
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  • The patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy). (Patients who have had a nipple-sparing mastectomy are eligible).
  • The patient must meet required laboratory values
  • Women of reproductive potential must agree to use an effective, non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy (chemotherapy or trastuzumab).
Ineligibility:
  • Definitive clinical or radiologic evidence of metastatic disease
  • Synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible).
  • Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible).
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.
  • Previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy.
  • Known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor® EL.

Pregnancy or lactation at the time of study entry.

Enrollment: • • About 3, 260 women from different cancer treatment centers will take part in this study.

Benefits:

Taking part in this study may or may not make your health better. While doctors hope that adding trastuzumab to chemotherapy will be more useful in treating HER2-low breast cancer compared to the usual treatment, there is no proof of this yet. We do know that the information from this study will help doctors learn more about trastuzumab given with chemotherapy as a treatment for HER2-low breast cancer. This information could help future breast 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 Oncology Clinical Research Coordinator, Beth Knetter at 715-847-2353 or 1-800-283-2881, ext.72353.

Created: Jun 3, 2011

Updated: Jan 18, 2013

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