Phase: Phase III
ClinicalTrials.gov ID number: NCT03337724
Sponsor of the trial: Hoffmann-LaRoche
Who is the trial for?
The IPATunity130 trial is currently enrolling people diagnosed with locally advanced or metastatic triple-negative breast cancer with a PIK3CA, AKT1, or PTEN genetic mutation. Triple-negative breast cancer is cancer that is estrogen-receptor-negative, progesterone-receptor-negative, and HER2-negative. Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, such as the chest wall. Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver. Both locally advanced and metastatic breast cancer are considered advanced-stage disease.
The trial is looking to see if adding the experimental medicine ipatasertib to Taxol (chemical name: paclitaxel), a taxane chemotherapy medicine, will offer more benefits than Taxol alone.
Note: The IPATunity130 trial also has an arm that includes people diagnosed with hormone-receptor-positive breast cancer, but that arm is no longer enrolling participants.
Why the trial is being done
Ipatasertib is an AKT inhibitor. AKT is a specific type of protein called a kinase. The PI3K/AKT pathway helps all cells — both healthy and cancer cells — get the energy they need. When this pathway is mutated or overactivated, which can happen if the cancer has a PIK3CA, AKT1, or PTEN mutation, it can allow cancer cells to survive and grow. AKT inhibitors block the AKT protein in this pathway with the goal of killing cancer cells.
Earlier research suggested that adding ipatasertib to Taxol to treat advanced-stage triple-negative breast cancer with a PIK3CA, AKT1, or PTEN mutation resulted in longer progression-free survival — about 4 months — compared to Taxol alone. Progression-free survival is how long a person lives without the cancer growing.
The IPATunity130 trial is a larger study looking to see if ipatasertib plus Taxol offers more benefits than Taxol alone in treating advanced-stage triple-negative breast cancer with a PIK3CA, AKT1, or PTEN mutation.
This trial is a double-blind placebo-controlled trial. Placebo-controlled means you will either receive ipatasertib and Taxol or placebo (a dummy pill) and Taxol. Double-blind means that neither you, your doctor, nor the study team will know which of these treatments you have been assigned.
Ipatasertib is a pill taken by mouth. Taxol is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or port at an infusion center.
In this study, ipatasertib is taken once per day on days 1 through 21 of each 28-day cycle. Taxol is given on days 1, 8, and 15 of the 28-day cycle.
Specific eligibility requirements
People are eligible for the IPATunity130 trial if they:
- have been diagnosed with advanced-stage triple-negative breast cancer with a PIK3CA, AKT1, or PTEN mutation
People are not eligible for the IPATunity130 trial if they:
- have received chemotherapy to treat advanced-stage triple-negative breast cancer
- have metastatic breast cancer lesions in the brain or spinal cord
- have been treated previously with an AKT inhibitor
- have an infection requiring antibiotic, antifungal, or antiviral medicines
- have been diagnosed with HIV
- have been diagnosed with liver disease
- have a history of inflammatory bowel disease
- have grade 2 or higher peripheral neuropathy
- have diabetes that requires insulin treatment
Possible side effects of the treatment being studied
In earlier studies, side effects seen in people treated with ipatasertib and Taxol included:
- neutropenia: low counts of a specific type of white blood cell
- feeling weak or tired
- peripheral neuropathy
- nausea and vomiting
- hyperglycemia: high levels of glucose in the blood
The IPATunity130 trial is being conducted at multiple sites around the world, including in the United States, Canada, Mexico, Europe, Australia, South America, and Russia. For a complete list of sites, visit the IPATunity130 ClinicalTrials.gov site.
For more information or to enroll
Visit the IPATunity130 ClinicalTrials.gov site.