FDA Approves Truqap for Certain Metastatic, Hormone Receptor-Positive Breast Cancers
On Nov. 16, 2023, the U.S. Food and Drug Administration (FDA) approved Truqap (chemical name: capivasertib) in combination with Faslodex (chemical name: fulvestrant) to treat locally advanced or metastatic, hormone receptor-positive, HER2-negative breast cancer with a mutation in the PIK3CA, AKT1, or PTEN genes if the metastatic cancer grew after treatment with at least one hormonal therapy medicine or if the locally advanced cancer grew in the year after treatment after surgery (adjuvant treatment) was completed.
Read the FDA announcement of Truqap’s approval.
Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from the breast. Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver.
About Truqap
Truqap is a targeted therapy medicine that stops the AKT protein from working. Research shows that the AKT protein is very important for the growth and survival of hormone receptor-positive, HER2-negative cancer cells.
Truqap is a pill taken by mouth.
Research on Truqap
The FDA approval was based on results from the CAPItello-291 trial, which compared Truqap and Faslodex to Faslodex alone to treat people diagnosed with inoperable locally advanced or metastatic, hormone receptor-positive, HER2-negative that had grown after being treated with an aromatase inhibitor.
Of the 708 people in the study, 289 people were diagnosed with breast cancers with a PIK3CA, AKT1, or PTEN mutation.
In the people diagnosed with breast cancer with one of the genetic mutations, progression-free survival (how long the people lived without the cancer growing) was:
7.3 months for people who received Truqap and Faslodex
3.1 months for people who received Faslodex alone
This difference was statistically significant, which means that it was likely due to the difference in treatment and not just because of chance.
In the people diagnosed with breast cancer without one of the mutations, progression-free survival was better in people who received Truqap and Faslodex, but the difference wasn’t statistically significant.
Listen to the episode of The Breastcancer.org Podcast featuring Dr. Nicholas Turner discussing the CAPItello-291 trial. The podcast was recorded in December 2022, before Truqap was approved.
Experimental Capivasertib Seems Promising for Advanced-Stage, Hormone Receptor-Positive, HER2-Negative Breast Cancer
Dec 15, 2022Truqap side effects
In the CAPItello-291 trial, the most common side effects caused by Truqap were:
skin reactions
high blood sugar levels
What this means for you
If you’ve been diagnosed with locally advanced or metastatic, hormone receptor-positive, HER2-negative breast cancer that has grown while being treated with an aromatase inhibitor, it makes sense to talk to your doctor about this study and ask that the cancer be tested for a mutation in the PIK3CA, AKT1, or PTEN genes.
If the cancer has one of these genetic mutations, you may be eligible to take Truqap.
— Last updated on June 10, 2025 at 4:12 PM