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A Phase I Study of CNF2024 Alone in Patients with HER2-Negative Advanced Breast Cancer or with Trastuzumab in Patients with HER2-Positive Advanced Breast Cancer
[Protocol 07-123]
- Full Title :
- A PHASE 1 OPEN-LABEL, DOSE-ESCALATION, SAFETY, PHARMACOKINETIC, AND PHARMACODYNAMIC STUDY OF CNF2024 AS A SINGLE AGENT TREATMENT IN SUBJECTS WITH HER2- ADVANCED BREAST CANCER OR IN COMBINATION WITH TRASTUZUMAB IN SUBJECTS WITH HER2+ ADVANCED CANCER
- Purpose :
CNF2024 is an investigational new drug that works by decreasing the levels of certain proteins in cancer cells, which may then cause the cancer cells to die. HER2 is a protein that is found in large quantities on some breast cancers and can make these tumors grow. Trastuzumab (Herceptin®) is an antibody treatment that binds to the HER2 protein and causes these cancer cells to die.
In this study, researchers want to determine the highest dose of CNF2024 that can be given safely to women with HER2-negative advanced breast cancer and in combination with trastuzumab in women with HER2-positive advanced breast cancer.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have unresectable locally advanced or metastatic HER2-negative or HER2-positive breast cancer that has progressed despite at least one regimen of hormonal therapy or chemotherapy. Patients with HER2-positive disease must have cancer that has progressed despite prior treatment with trastuzumab.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Shanu Modi at 646-888-5243.
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