Clin Cancer Res: Efficacy and safety of ribociclib combined with exemestane + everolimus in the treatment of advanced HR+/HER2- advanced breast cancer with CDK4/6 inhibitors: stage I/II TRINITI-1 Research

For hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer , the current recommended standard treatment is endocrine therapy (ET) combined with CDK4/6 inhibitor (CDK4/6i)
.

However, the optimal treatment for progression after CDK4/6i treatment is unclear

For hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer , the current recommended standard treatment is endocrine therapy (ET) combined with CDK4/6 inhibitor (CDK4/6i)

This is a multi-center, open-label Phase I/II clinical study
.

The phase I study determined the maximum tolerated dose (MTD) of ribociclib, exemestane, and everolimus, defined as dose-limiting toxicity in <30% of patients

This is a multi-center, open-label Phase I/II clinical study

A total of 104 patients with endocrine resistance (all women) were enrolled, of which 25 cases were included in the phase I study, and 79 cases were included in the phase II study

Research Overview

 Research Overview

95 patients who were resistant to previous endocrine therapy can be evaluated for efficacy, and the CBR at week 24 was 41.
1% (95% CI, 31.
1-51.
6 )
.

The CBRs in the 24th week of the group 1 dose treatment and the group 2 dose treatment were relatively close, 44.

95 patients who were resistant to previous endocrine therapy can be evaluated for efficacy, and the CBR at week 24 was 41.

Efficacy evaluation

Efficacy evaluation

In the efficacy evaluation population, the median follow-up time was 3.
1 months, the median PFS was 5.
7 months (95% CI, 3.
6–9.
1 months); the 1-year PFS rate was 33.
4% (95% CI, 22.
8%–44.
4%) )
.

The median OS has not been reached at the time of data analysis

In the efficacy evaluation population, the median follow-up time was 3.

PFS

 PFS

104 patients were evaluated for safety.
The most common hematological adverse event (AEs) (and also the most common AEs in the overall population) was neutropenia (69.
2% for all grades; 51.
0% for grade 3/4)
.

Other common hematological or laboratory abnormalities include anemia (28.

104 patients were evaluated for safety.

Adverse events

Adverse events

In summary, the TRINITI-1 study shows that for patients with endocrine resistance HR+/HER2-advanced breast cancer who have progressed after treatment with CDK4/6 inhibitors (CDK4/6i), block CDK4/6 and PI3K/AKT/mTOR pathways It shows anti-tumor efficacy and safety, which is worthy of further exploration
.

In summary, the TRINITI-1 study shows that for patients with endocrine resistance HR+/HER2-advanced breast cancer who have progressed after treatment with CDK4/6 inhibitors (CDK4/6i), block CDK4/6 and PI3K/AKT/mTOR pathways It shows anti-tumor efficacy and safety, which is worthy of further exploration
.
The TRINITI-1 study showed that for patients with endocrine resistant HR+/HER2-advanced breast cancer who developed endocrine resistance after treatment with CDK4/6 inhibitors (CDK4/6i), they showed resistance to CDK4/6 and PI3K/AKT/mTOR pathway blockade.
Tumor efficacy and safety are worthy of further exploration
.
The TRINITI-1 study showed that for patients with endocrine resistant HR+/HER2-advanced breast cancer who developed endocrine resistance after treatment with CDK4/6 inhibitors (CDK4/6i), they showed resistance to CDK4/6 and PI3K/AKT/mTOR pathway blockade.
Tumor efficacy and safety are worthy of further exploration
.

Original source:

Original source:

Aditya Bardia, Sara A Hurvitz, Angela DeMichele, et al.
Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR +/HER2-Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1).
Clin Cancer Res.
2021 Mar 15.
doi: 10.
1158/1078-0432.
CCR-20-2114.
Online ahead of print.

Aditya Bardia, Sara A Hurvitz, Angela DeMichele, et al.
Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR +/HER2-Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1).
Clin Cancer Res.
2021 Mar 15.
doi: 10.
1158/1078-0432.
CCR-20-2114.
Online ahead of print.
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