Clinical Trial NU EM11B03
- Phase II trial of EVEROLIMUS ± Trastuzumab in hormone-refractory metastatic breast cancer
- Principal Investigator
- Cesar Santa-Maria
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU EM11B03
- The purpose of this study is to investigate if trastuzumab or everolimus is effective for breast cancers that are no longer controlled with (resistant to) hormonal therapies, and have small to moderate amounts of HER2/neu.
- Breast cancers that become resistant to hormonal therapies, such as tamoxifen and aromatase inhibitors, often have small to moderate amounts of a protein, called HER2/neu. Trastuzumab is an antibody which targets this HER2/neu protein. Participants in this study have breast cancer that did not express high levels of HER2/neu when they were diagnosed, which is why they were not already treated with trastuzumab. Agents that target another protein in breast cancer cells called mTOR, such as everolimus, have been noted to make cancer cells more sensitive to hormonal therapies and trastuzumab. There is no standard of care for the disease once it becomes resistant to hormonal therapy, and many patients are treated with chemotherapy. Based on laboratory findings, it is believed that trastuzumab, in combination with the most recent hormonal therapy received, may be effective in breast cancers that are 1) no longer controlled with hormonal therapies and 2) have small to moderate levels of HER2/neu. Everolimus targets a protein called mTOR which appears to become more active in breast cancers that are no longer controlled by hormonal therapies.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have breast cancers that become resistant to hormonal therapies.
- Participants must not have had prior treatment with trastuzumab or other HER2-directed therapies or with an mTOR inhibitor.
- Description of Treatment
- In this study participants will be randomly chosen to receive either trastuzumab alone or everolimus alone. Trastuzumab is a liquid, which will be infused directly into the vein through a tube. Participants will have to be at the clinic to receive trastuzumab. Everolimus is a pill that will be taken every day.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized, Multicenter, Open Label Study of MM-302 plus Trastuzumab vs. Chemotherapy of Physician’s Choice plus Trastuzumab in Anthracycline Naive Patients with Locally Advanced/Metastatic HER2-Positive Breast Cancer
- A Phase II Single Arm Study of Palbociclib in Patients with Metastatic HER2-positive and Triple Negative Breast Cancer with Brain Metastasis
last updated: 25-Oct-16 10:55 PM
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