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A Phase Ib Study of Trastuzumab-MCC-DM1, Paclitaxel, and Pertuzumab in Patients with HER2-Positive, Locally Advanced or Metastatic Breast Cancer Who Previously Received Trastuzumab
[Protocol 09-093]
- Full Title :
- A PHASE 1B, OPEN-LABEL, DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TRASTUZUMAB MCC DM1, PACLITAXEL AND PERTUZUMAB ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH HER2 POSITIVE, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE PREVIOUSLY RECEIVED A TRASTUZUMAB CONTAINING REGIMEN
- Purpose :
Paclitaxel and trastuzumab are anticancer drugs commonly used to treat breast cancer. In this study, researchers want to assess the safety and effectiveness of combining paclitaxel, trastuzumab-MCC-DM1 (T-DM1), and pertuzumab in women with HER2-positive locally advanced or metastatic breast cancer.
T-DM1 and pertuzumab are investigational drugs. T-DM1 is made by linking a chemotherapy drug called DM1 to trastuzumab. T-DM1 works by attaching to the HER2 protein on cancer cells and then releasing the chemotherapy inside the cancer cells.
Pertuzumab is an antibody protein that also attaches to HER2 on cancer cells. T-DM1 and pertuzumab have demonstrated anticancer activity in laboratory studies. The effect was even stronger when T-DM1 and pertuzumab were given together instead of being given alone.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of HER2-positive locally advanced or metastatic breast cancer.
- Patients must have previously received trastuzumab, but not T-DM1 or pertuzumab.
- At least 3 weeks must have passed since completion of prior therapy (4 weeks since major surgery) and entry into the study.
- 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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