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A Phase II Study Evaluating IPI-504 Plus Trastuzumab in Patients with Pretreated Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

[Protocol 09-033]


Full Title :
A PHASE II MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF IPI-504 IN COMBINATION WITH TRASTUZUMAB IN PATIENTS WITH PRETREATED, LOCALLY ADVANCED OR METASTATIC HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR2 (HER2) POSITIVE BREAST CANCER
Purpose :

Trastuzumab is an anticancer drug used to treat breast cancer that contains receptors for a protein called HER2. However, some tumors continue to grow despite trastuzumab therapy.

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called retaspimycin (IPI-504) when given in combination with trastuzumab in women with HER2-positive locally advanced or metastatic breast cancer that persists despite prior trastuzumab treatment. Retaspimycin blocks a protein called heat shock protein-90 (Hsp90), which could make cancer cells more sensitive to the effects of trastuzumab.

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 locally advanced or metastatic breast cancer that persists despite at least two prior regimens that contained a HER2-targeted agent (such as trastuzumab and lapatinib).
  • At least 3 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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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