AiRuiKang (dalpiciclib)

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

P1, N=6, Recruiting, West China Hospital

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

This trial will provide evidence of the tolerability, safety, and efficacy of dalpiciclib in combination with apatinib in metastatic sarcoma patients who have failed first-line systemic treatment.

P=N/A, N=24, Active, not recruiting, Shengjing Hospital | Trial completion date: Oct 2023 --> Dec 2028 | Trial primary completion date: Jul 2023 --> Dec 2024

CDK4/6 inhibitors that have been marketed in China include Ribociclib, Palbociclib, Abemaciclib and Dalpiciclib. In order to further improve the standardized application of CDK4/6 inhibitors in China, the Breast Cancer Expert Committee of the National Center for Cancer Quality Control and the Professional Committee of Clinical Research of Cancer Drugs of the Chinese Anti-Cancer Association organized the related expert to update the consensus based on the "CDK4/6 inhibitor consensus on clinical application of in the treatment of hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer (2021 edition)" . The updated consensus systematically introduces the pharmacological characteristics, drug monitoring and adverse event management, etc., of CDK4/6 inhibitors to promote the accuracy of clinical decision-making with the ultimate goal to prolong the overall survival of patients and improve the quality of life.

P1/2, N=146, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting --> Recruiting

Ribociclib+fulvestrant probably represents the best option in a first-line setting. When combined with NSAI, dalpiciclib likely showed the best efficacy but the worst safety. Abemaciclib+NSAI and ribociclib+NSAI could also be promising treatments, while palbociclib presented inferiority. (PROSPERO Registration No. CRD42022370271).

P1/2, N=146, Not yet recruiting, Shandong Suncadia Medicine Co., Ltd.

P2, N=30, Not yet recruiting, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiaotong University Scho

P2, N=82, Recruiting, Tongji Hospital

P1/2, N=104, Completed, Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting --> Completed

P2, N=53, Recruiting, Zhejiang Cancer Hospital

However, the role of angiogenesis inhibitors, such as bevacizumab, in these patients (pts) is controversial...Our phase Ib/II trial (NCT05176080, ChiCTR2100053950) aims to evaluate the safety and efficacy of a novel anti-angiogenesis TKI famitinib (F) added to dalpiciclib (D) and ET in advanced HR-positive and HER2-negative BC... The anti-angiogenesis multi-targeted receptor TKI famitinib combined with CDK4/6i and fulvestrant has shown antitumor effects in advanced HR-positive and HER2-negative BC, and no new safety signals were observed.

Dalpiciclib is a novel CDK4/6 inhibitor developed independently in China, which has been approved for use in combination with fulvestrant for the treatment of HR-positive/HER2-negative recurrent or metastatic breast cancer in patients who have experienced disease progression after prior endocrine therapy, or in combination with aromatase inhibitors as initial treatment for HR-positive/HER2-negative locally advanced or metastatic breast cancer patients. The combination of dalpiciclib and letrozole has shown efficacy in downstaging and shrinking tumors in patients with early or locally advanced HR-positive/HER2-negative breast cancer. Patients who exhibit a positive response in the assessment after 4 cycles may consider it as a viable option for chemo-free neoadjuvant treatment.

In China, dalpiciclib (a CDK4/6 inhibitor) in combination with fulvestrant has been approved for patients with recurrent or metastatic HR-positive/HER2-negative breast cancer who have failed ET. The first participant was enrolled on 18 January 2023. The recruitment is ongoing.

This is the first prospective study of neoadjuvant dalpiciclib in patients with HR-positive, HER2-negative breast cancer. The findings suggest the promising tumor response to neoadjuvant dalpiciclib plus letrozole in postmenopausal patients with HR-positive, HER2-negative breast cancer, with a manageable safety profile. This combination can effectively suppress the tumor cell proliferation, as reflected by change in Ki-67 level.

P1, N=12, Recruiting, West China Hospital

P2, N=144, Recruiting, Hebei Medical University Fourth Hospital

P1, N=660, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.

These findings suggest that this combination may have promising activity and manageable toxicity. Further investigation is needed.

Until the clinical studies, guideline recommendations, prices, and many other aspects of this assessment are updated, abemaciclib and palbociclib, which have the top 2 scores, can be used as a priority recommendation for Chinese medical institutions to select CDK4/6 inhibitors and optimize the use of the drug catalog based on the scoring results of this assessment.

P1, N=3, Terminated, Jiangsu HengRui Medicine Co., Ltd. | N=76 --> 3 | Trial completion date: Oct 2023 --> Jun 2023 | Recruiting --> Terminated; Sponsor R & D Strategy Adjustment

P2, N=178, Not yet recruiting, Shuangyue Liu

P2; N=265; Not yet recruiting; Sponsor:Fudan University

P2, N=50, Recruiting, Sun Yat-sen University

Five CDK4/6 inhibitors, palbociclib, ribociclib, abemaciclib, dalpiciclib, and trilaciclib have been approved for the treatment of this breast cancer subset at present. Possible approaches to overcome CDK4/6 inhibitors resistance were further discussed. For example, using another CDK4/6 inhibitor, PI3K inhibitor, mTOR inhibitor, or a novel drug.

P1, N=20, Completed, Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting --> Completed

No abstract available

Our findings suggest that dalpiciclib plus letrozole or anastrozole could be a novel standard first-line treatment for patients with hormone receptor-positive, HER2-negative advanced breast cancer, and is an alternative option to the current treatment landscape.

P3, N=80, Recruiting, Peking Union Medical College Hospital

P2, N=338, Recruiting, Fudan University | Not yet recruiting --> Recruiting

P1/2, N=65, Active, not recruiting, Henan Cancer Hospital | Recruiting --> Active, not recruiting