This phase 2 clinical trial is evaluating the safety and effectiveness of targeted therapy TAS-120 (futibatinib) alone or in combination with fulvestrant (Faslodex) in patients with metastatic breast cancer (mBC). The main outcomes to be evaluated will be the response rate and survival without cancer worsening.
Breast cancer (BC) that has spread to other organs (metastatic) is difficult to treat. Many of these tumors have abnormalities (mutations) that reduce the effectiveness of current cancer therapies. One abnormality is in the fibroblast growth factor receptor (FGFR). FGFR is a protein that if damaged leads to abnormal tumor growth. TAS-120 is a targeted therapy that blocks FGFR and has shown anti-tumor activity.
Fulvestrant is a hormonal therapy. Many BCs grow in response to the hormone estrogen through a protein present on cancer cells called an estrogen receptor (ER). Fulvestrant reduces the number of ERs on BC cells and changes their shape therefore stopping their activity.
This trial is evaluating the safety and effectiveness of TAS-120 alone or in combination with fulvestrant in patients with mBC. The main outcomes to be evaluated will be the response to treatment and survival without cancer worsening.
Who are they looking for?
This trial is recruiting 168 people with mBC that have previously been treated. Participants must have a tumor tissue for FGFR testing and must have adequate liver, kidney, and bone marrow function, and normal phosphorus levels.
Participants must not have abnormalities of the calcium-phosphorus metabolism and must not have calcium deposits in organs such as the bowels, heart, lungs, kidneys, or eyes. Participants must not have received previous treatment with other FGFR inhibitors or fulvestrant. Female participants must not be pregnant or breastfeeding. Patients with serious medical conditions that might interfere with the study will also be excluded.
How will it work
There will be 2 treatment groups. One group will receive TAS-120 tablets alone and one group will receive TAS-120 tablets and fulvestrant intramuscular (IM; into the muscle) injections.
Participants will be followed up for 12 months for a response to treatment, survival without cancer worsening, and side effects.