A Phase II clinical trial (study) of a new treatment continues to test the short-term safety (including short-term side effects) of a new treatment in patients, to determine the maximum dose of the treatment that can be given safely, and begins to evaluate the minimum dose of the treatment that can be given to produce a good effect, and to find out how well the new treatment works in the patients.
Often, Phase II clinical trials of a new treatment are tested in approximately 100 to 250 patients. In a Phase II clinical trial of a new treatment for breast cancer, usually a particular type or stage of breast cancer is studied. |
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