Capivasertib Combo May Lead to QOL Improvement in Advanced HR+, HER- Breast Cancer


Paolo Tarantino, MD, gives an overview on how the recently approved combination of capivasertib plus fulvestrant can help improve treatment strategies for patients with locally advanced or metastatic breast cancer that is hormone receptor–positive, HER2-negative breast cancer

Following the FDA approval of capivasertib plus fulvestrant (Faslodex) for patients with locally advanced or metastatic, hormone receptor–positive, HER2-negative breast cancer with 1 or more PIK3CAAKT1, or PTEN alterations, Paolo Tarantino, MD, a medical oncologist from Dana-Farber Cancer Institute, highlighted how this combination can impact patients’ quality of life.1

Results from the phase 3 CAPItello-291 trial (NCT04305496) led to the combination’s approval.2 In the overall population, median progression-free survival (PFS) in the capivasertib plus fulvestrant group was 7.2 months (95% CI, 7.2-7.4) vs 3.6 months (95% CI, 2.8-3.7) in the placebo group (HR, 0.60; 95% CI, 0.51-0.71; P <.001). For patients who had an AKT pathway alteration, the median PFS was 7.3 months (95% CI, 5.5-9.0) in the combination group vs 3.1 months (95% CI, 2.0-3.7) in the placebo group (HR, 0.50; 95% CI, 0.38-0.65; P <.001).


For the setting in which capivasertib was tested, it tackled an important unmet need that we currently have in breast oncology because it was tested among patients who have progressed on prior to aromatase inhibitors; most of the patients also [had received] CDK4/6 inhibitors. These drugs work very well when utilized in the first line. When we move to the second line, it’s hard to achieve the same progression-free survival, and the same activity that we see in the first line.

We do need innovation—we do need novel drugs in the second-line setting and beyond, for hormone receptor–positive metastatic breast cancer. The phase 3 trial CAPItello-291 showed that we could potentially have the first agent targeting AKT [pathways] that is potentially approved and may help to treat certain patients with HER2-positive, HER2-negative metastatic breast cancer with activity that is very intriguing that promises also to have an impact on the quality of life of these patients.

At the same time with [adverse] effects, whenever we have a new approval, it is important to start learning how to manage the [adverse] effects because we do know that there is a curve of learning and that in time, we get better at treating those. In this case, the quality of life of patients can be optimized.


  1. FDA approves capivasertib with fulvestrant for breast cancer. News release. FDA. November 16, 2023. Accessed November 17, 2023.
  2. Turner NC, Oliveira M, Howell SJ, et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070. doi:10.1056/NEJMoa2214131

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