AiRuiKang (dalpiciclib)

P=N/A, N=52, Not yet recruiting, Fujian Medical University

The combination of CDK4/6i and ET significantly improves PFS and OS compared to ET alone in both Asian and non-Asian patients with HR+/HER2-aBC. Although the magnitude of benefit appears to be independent of ethnicity, future clinical trials should devise a standardized method for stratifying patients by ethnicity to more effectively assess potential differences in treatment benefits.

P2, N=35, Recruiting, Peking University

P4, N=40, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

P4, N=40, Recruiting, The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University

Dalpiciclib plus fulvestrant is effective and comparatively safe in postmenopausal women with hormone receptor-positive and HER2-negative breast cancers. Dalpiciclib, buparlisib, fulvestrant, and ribociclib cause neutropenia, severe depression, adverse gastroenterological effects, and adverse hepatological effects, respectively.

P2, N=100, Not yet recruiting, Peking University

P3, N=1388, Active, not recruiting, Fudan University

P2, N=620, Recruiting, Fudan University | N=140 --> 620

P4, N=30, Not yet recruiting, Jiangsu Famous Medical Technology Co., Ltd.

P2, N=30, Not yet recruiting, Harbin Medical University

Cross-line CDK4/6i therapy is associated with significant clinical benefits and manageable safety profiles in patients with HR+/HER2- ABC, which underscores cross-line CDK4/6i therapy potential as an effective treatment strategy.

Compared with aromatase inhibitor (AI), palbociclib plus AI (PalboAI) exhibited a significantly longer PFS up to the 36th month of follow-up [HR=1.7; 95% credible interval, 1.36-2.16], including on the 3rd [OR=2.22; 95% confidence interval (CI), 1.10-4.47], 6th (OR=2.39; 95% CI, 1.21-4.69), 12th (OR=1.94; 95% CI, 1.34-2.79), 18th (OR=2.38; 95% CI, 1.65-3.44), 24th (OR=2.39; 95% CI, 1.67-3.43), 30th (OR=2.10; 95% CI, 1.62-2.74) and 36th (OR=2.66; 95% CI, 1.37-5.18) month of follow-up. Additionally, abemaciclib plus fulvestrant exhibited significant effects compared with AI alone between 12 and 36 months. Ribociclib plus fulvestrant, ribociclib plus AI and dalpiciclib plus AI exerted significant effects compared with AI alone between 12 and 30 months. Considering the effect on OS and PFS together with adverse reactions, safety, medical compliance and route of administration, PalboAI was found to be the optimal treatment for HR+/HER2-mBC. However, additional head-to-head clinical trials are warranted to confirm these findings.

The recommended phase III dose of dalpiciclib was 150 mg. ClinicalTrials.gov identifier: NCT03481998.

P2, N=155, Not yet recruiting, Beijing 302 Hospital

P2, N=30, Not yet recruiting, Fudan University

P1, N=102, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Enrolling by invitation --> Recruiting | Trial primary completion date: Jun 2024 --> Dec 2024

P2, N=716, Recruiting, Fudan University | Phase classification: P1/2 --> P2

P=N/A, N=200, Recruiting, Fudan University | N=150 --> 200

P3, N=5274, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Enrolling by invitation --> Active, not recruiting

Previous studies have shown that SHR6390 in combination with rifampicin, a potent inducer of CYP3A4, significantly reduces exposure levels. It is recommended to avoid concomitant administration of moderate inducers of CYP3A4 during treatment with SHR6390. http://www.chinadrugtrials.org.cn/index.html, CTR20211571/ https://classic.clinicaltrials.gov, NCT04973020.

P1, N=6, Recruiting, West China Hospital | N=12 --> 6

P=N/A, N=17, Completed, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiaotong University Scho | Recruiting --> Completed

P=N/A, N=46, Not yet recruiting, The Fist Affiliated Hospital of Jinzhou Medical University; The Fist Affiliated Hospital of Jinzhou Medical University

P=N/A, N=200, Not yet recruiting, The First Affiliated Hospital of Army Medical University; The First Affiliated Hospital of Army Military Medical University

P4, N=317, Not yet recruiting, Dongguan Donghua Hospital; Dongguan Donghua Hospital

P4, N=30, Not yet recruiting, An Yang Tumor Hospital; An Yang Tumor Hospital

P2, N=50, Recruiting, SHANXI PROVINCIAL CANCER HOSPITAL; SHANXI PROVINCIAL CANCER HOSPITAL

P2, N=30, Recruiting, Breast Surgery of the First Hospital of China Medical University; The First Affiliated Hospital of China Medical University

P2, N=112, Recruiting, Sun Yat-Sen University Cancer Center; Sun Yat-Sen University Cancer Center

P2, N=36, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

A total of 20 randomized controlled trials (RCTs) were included in this study, investigating the effectiveness of four CDK4/6 inhibitors-Abemaciclib, Dalpiciclib, Ribociclib, and Palbociclib-when combined with ET for the treatment of HR+/HER2-breast cancer. On the other hand, Dalpiciclib + ET likely demonstrates the best efficacy in terms of PFS but exhibits the poorest safety profile, particularly in relation to neutropenia. Therefore, clinicians should exercise increased vigilance in monitoring and managing adverse effects when prescribing Abemaciclib + ET and Dalpiciclib + ET.

P2, N=32, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P=N/A, N=150, Recruiting, Fudan University

P2, N=1163, Recruiting, The First Affiliated Hospital with Nanjing Medical University

We aimed to assess the cost-effectiveness of dalpiciclib plus letrozole/anastrozole (non-steroidal aromatase inhibitor [NSAI]) compared with abemaciclib plus NSAI as a first-line treatment for HR+/HER2- ABC in China. At a willingness-to-pay threshold of 3 times gross domestic product per capita in China for 2023 ($37721.5/QALY), the cost-effectiveness probability of dalpiciclib plus NSAI was 77.42%. From the perspective of Chinese payers, dalpiciclib plus NSAI appears to be a cost-effective strategy compared with abemaciclib plus NSAI for the first-line treatment of patients with HR+/HER2- ABC in China.

P=N/A, N=103, Not yet recruiting, RenJi Hospital

Triple-positive breast cancer (TPBC) poorly responds to current standard neoadjuvant therapy (trastuzumab plus pertuzumab and chemotherapy). This four-drug neoadjuvant regimen shows promising pathological response with an acceptable safety profile in patients with TPBC. A randomized controlled trial (NCT05638594) of this regimen is being conducted.

P1/2, N=306, Recruiting, Risen (Suzhou) Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting

P1/2, N=72, Active, not recruiting, Fudan University | Phase classification: P2 --> P1/2

P2, N=30, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | N=120 --> 30

P2; Not yet recruiting --> Recruiting