There are 3 phases to the I-SPY 2 trial:
The Screening Phase is when your tumor and overall health (heart, kidney, and liver function) are assessed to determine if you meet the criteria to participate in the trial. You will have a biopsy of the tumor, which is evaluated by a molecular test called MammaPrint®. MammaPrint determines if a tumor has a high risk of recurrence if it is treated with surgery alone and not treated with chemotherapy.
The Treatment Phase is when you will receive your assigned drug treatment. Chemotherapy treatment will range from 12 to 36 weeks of:
Standard treatment chemotherapy An investigational drug with or without standard chemotherapy If your tumor is HER2 positive you will also receive a HER2 targeted standard treatment (traztuzumab and pertuzumab).
Next, you may receive 4 doses of the drugs Adriamycin and cyclophosphamide (called AC, for short), over the next 12 weeks, which is standard treatment.
If your tumor has completely responded to your first 12 weeks of treatment, as seen on an MRI and through a biopsy, you and your doctor may decide that Adriamycin and cyclophosphamide (AC) treatment is not necessary before surgery.
The treatment phase is divided into three different treatments as noted below:
Treatment A will be 12 weeks of a novel treatment targeted to your tumor’s Response Predictive Subtype.
If your tumor responds completely to Treatment A as seen on an MRI and through a biopsy, you and your doctor may decide that Treatment B is not necessary. You will be given the option to go directly to surgery. If your tumor is showing minimal response to treatment A, you will move onto Treatment B early.
If there is no Treatment A option for your tumor type when you join the trial, you will start with Treatment B.
Treatment B will be 12 to 18 weeks of standard treatment chemotherapy.
If your tumor is HER2 positive you may also receive a HER2 targeted standard treatment (traztuzumab and pertuzumab).
If your tumor responds completely to Treatment B you will be given the option to go to surgery early. If your tumor shows only minimal response to Treatment B, you will move to Treatment C.
Treatment C will be 8 to 12 weeks of:1) Adriamycin and cyclophosphamide (called AC, for short).
After you have completed Treatment C you will have surgery.
For the Endocrine Therapy Treatment Phase patients are randomly assigned to receive either an investigational oral SERD (Selective Estrogen Receptor Degrader) drug (Amcenestrant) alone or in combination with another investigational targeted drug (Letrozole (AI) or Abemaciclib) for 6 months.
Response to your treatment will be monitored by MRI (Magnetic Resonance Imaging) to see any change in your tumor size. Blood and breast tissue samples are collected to use for research at several times during the trial. Following treatment, you will have surgery to remove any remaining tumor. Any additional treatment after surgery, if needed, will be decided by you and your study doctor.
During the Follow-Up Phase a member of your study care team will check on your health after 6 months and then annually for ten years. They will do a blood draw for research once a year for at least five years.
