Capivasertib + Fulvestrant for Breast Cancer

(SAFE-CAP Trial)

This trial tests a combination of two treatments, capivasertib (a new potential drug) and fulvestrant, to determine if they can reduce common side effects like rashes and diarrhea in individuals with a specific type of advanced breast cancer. It targets those with hormone receptor-positive, HER2-negative breast cancer that has worsened despite prior treatments. Participants should have experienced cancer progression and be eligible to take the study medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial protocol does not clearly specify if you need to stop taking your current medications. However, you may need to stop certain medications, especially if they interfere with the study drugs. It's best to discuss your current medications with the trial team to get specific guidance.

A previous study identified common side effects of the combination of capivasertib and fulvestrant, including diarrhea (72.4% of patients), rash (38.0%), and nausea (34.6%). Some patients experienced more serious side effects, such as severe rash. Rare but serious events, like infections such as sepsis and heart attacks, occurred in about 1.3% of patients. However, this combination delayed cancer progression compared to fulvestrant alone. While side effects are common, the treatment can be effective. Prospective participants should discuss potential side effects with the trial team.¹²³⁴⁵

Researchers are excited about capivasertib combined with fulvestrant for breast cancer treatment because capivasertib is an innovative drug that targets the AKT pathway, which is crucial for cancer cell growth and survival. Unlike standard treatments such as chemotherapy or hormone therapy alone, this combination aims to tackle cancer at a molecular level, potentially increasing effectiveness and reducing resistance. Additionally, the inclusion of prophylactic measures for rash and diarrhea makes the treatment more patient-friendly by managing side effects proactively.

Research has shown that combining capivasertib with fulvestrant can help treat advanced hormone receptor-positive (HR+) breast cancer. In one study, patients who received this combination lived without their cancer worsening for an average of 7.2 months, compared to 3.6 months for those who did not receive capivasertib. Another study found that patients lived about 6.9 months longer with this treatment. Additionally, the cancer responded better to the treatment with capivasertib and fulvestrant than with a placebo. These findings suggest that adding capivasertib to fulvestrant can lead to better outcomes for this type of breast cancer. Participants in this trial will receive capivasertib and fulvestrant, with some receiving additional prophylactic treatments to manage potential side effects.²⁴⁶⁷⁸