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Protocol No. 2009UC147 Principal Investigator Yee, Douglas
Phase Phase II (Cancer Prevention)
Age Group Adult Scope National
Secondary Protocol No. I-SPY 2
Title Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis (ISPY2)
Objective The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response are predictors of treatment success.
Treatment All patients will receive standard chemotherapy, paclitaxel [T] with or without a phase II investigational agent followed by doxorubicin and cyclophosphamide (AC).
Description All patients with locally advanced breast cancer (T2-4, any N, M0) will receive neoadjuvant chemotherapy with 12 weekly doses of T. They will be randomized to receive this chemotherapy backbone with or without a phase II investigational agent. Pre-, mid-, and post-treatment research biopsies and MRIs will be utilized to monitor response to therapy and develop predictive biomarkers. AC will be given after T.
Key Eligibility Patient must have newly diagnosed, operable, histologically confirmed invasive cancer of the breast. Tumor size must be at least 2.5 cm. Inflammatory breast cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites of metastasis allowed.
Applicable Disease Sites Breast - Female
Therapies Involved Chemotherapy
Immunotherapy - Drugs
Drugs Involved PLX3397
Pembrolizumab (Keytruda
MK-3475)
Talazoparib (BMN-673)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patients must be at least 18 years of age and have not had any prior chemotherapy or radiation therapy to the ipsilateral breast for this malignancy. Women who are pregnant or nursing are not eligible. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible. Must have normal organ and marrow function, no uncontrolled or severe cardiac disease or clinical or imaging evidence of distant metastases. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
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