^
    3d
    Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=35, Recruiting, Peking University
    New P2 trial
    |
    Irene (pyrotinib) • AiRuiKang (dalpiciclib)
    4d
    Prospective, randomized, cohort clinical study of Dalpicilib combined with letrozole or neoadjuvant chemotherapy in the treatment of ER high expression luminal A early breast cancer (ChiCTR2400090520)
    P4, N=40, Recruiting, The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    letrozole • AiRuiKang (dalpiciclib)
    4d
    A single arm, multicenter, exploratory clinical study of CDK4/6 inhibitor dalpiciclib combined with letrozole, pyrotinib maleate and trastuzumab in the preoperative treatment of stage II-III triple positive breast cancer (TPBC) (ChiCTR2400090352)
    P4, N=40, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • letrozole • AiRuiKang (dalpiciclib)
    11d
    Comparative efficacy & safety of buparlisib plus fulvestrant, fulvestrant plus dalpiciclib, and ribociclib plus letrozole for postmenopausal, hormone receptor-positive, and HER2-negative breast cancer. (PubMed, Clinics (Sao Paulo))
    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.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Kisqali (ribociclib) • fulvestrant • letrozole • buparlisib (AN2025) • AiRuiKang (dalpiciclib)
    25d
    Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Peking University
    New P2 trial
    |
    CDK4 (Cyclin-dependent kinase 4)
    |
    EndoPredict®
    |
    letrozole • AiRuiKang (dalpiciclib)
    1m
    Dalpicilib-Enhanced Vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer (clinicaltrials.gov)
    P3, N=1388, Active, not recruiting, Fudan University
    New P3 trial
    |
    AiRuiKang (dalpiciclib)
    1m
    BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov)
    P2, N=620, Recruiting, Fudan University | N=140 --> 620
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
    |
    Avastin (bevacizumab) • sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • SHR-A2102 • SHR-A1921 • SHR-A2009
    2ms
    An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P4, N=30, Not yet recruiting, Jiangsu Famous Medical Technology Co., Ltd.
    New P4 trial
    |
    AiRuiKang (dalpiciclib)
    2ms
    Adebrelimab Combined with Dalpiciclib and Standard Endocrine Therapy for HR + / HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Harbin Medical University
    New P2 trial
    |
    AiRuiKang (dalpiciclib) • Ariely (adebrelimab)
    2ms
    Clinical benefit and safety profile of cross-line therapy with CDK4/6 inhibitors: a retrospective study of HR+/HER2- advanced breast cancer. (PubMed, Cancer Biol Med)
    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.
    Retrospective data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • AiRuiKang (dalpiciclib)
    2ms
    First‑line endocrine therapy for hormone receptor positive and HER‑2 negative metastatic breast cancer: A Bayesian network meta‑analysis. (PubMed, Oncol Lett)
    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.
    Retrospective data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • AiRuiKang (dalpiciclib)
    2ms
    Dalpiciclib in combination with letrozole/anastrozole or fulvestrant in HR-positive and HER2-negative advanced breast cancer: results from a phase Ib study. (PubMed, Ther Adv Med Oncol)
    The recommended phase III dose of dalpiciclib was 150 mg. ClinicalTrials.gov identifier: NCT03481998.
    P1 data • Journal • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    fulvestrant • letrozole • anastrozole • AiRuiKang (dalpiciclib)
    3ms
    Exploration of Dalpiciclib + Tucidinostat in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor (clinicaltrials.gov)
    P2, N=155, Not yet recruiting, Beijing 302 Hospital
    New P2 trial • Metastases
    |
    Epidaza (chidamide) • AiRuiKang (dalpiciclib)
    3ms
    Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University
    New P2 trial
    |
    AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    3ms
    A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=102, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Enrolling by invitation --> Recruiting | Trial primary completion date: Jun 2024 --> Dec 2024
    Enrollment status • Trial primary completion date • Metastases
    |
    AiRuiKang (dalpiciclib)
    3ms
    FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
    P2, N=716, Recruiting, Fudan University | Phase classification: P1/2 --> P2
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Ariely (adebrelimab) • SHR-A1921
    3ms
    Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, Fudan University | N=150 --> 200
    Enrollment change • Real-world evidence • Real-world • Metastases
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • AiRuiKang (dalpiciclib)
    4ms
    Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative (clinicaltrials.gov)
    P3, N=5274, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Enrolling by invitation --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    AiRuiKang (dalpiciclib)
    4ms
    Effect of Efavirenz on the Pharmacokinetics of SHR6390 in Healthy Volunteers. (PubMed, Drug Des Devel Ther)
    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.
    Clinical • PK/PD data • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    AiRuiKang (dalpiciclib) • efavirenz • rifampicin
    4ms
    Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas (clinicaltrials.gov)
    P1, N=6, Recruiting, West China Hospital | N=12 --> 6
    Enrollment change
    |
    AiRuiKa (camrelizumab) • AiRuiKang (dalpiciclib)
    4ms
    SHR6390 in Treating Patients with Recurrent and/or Metastatic Mucosal Melanoma of Head and Neck Harboring CDK4 Amplification (ChiCTR2000031608)
    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
    Trial completion
    |
    CDK4 (Cyclin-dependent kinase 4)
    |
    AiRuiKang (dalpiciclib)
    4ms
    Pyrotinib Plus Dalpiciclib Plus Endocrine therapy in hormone receptor positive and HER2 positive advanced breast cancer: a multi-center, prospective, single-arm, phase 2 trial (ChiCTR2400083548)
    P=N/A, N=46, Not yet recruiting, The Fist Affiliated Hospital of Jinzhou Medical University; The Fist Affiliated Hospital of Jinzhou Medical University
    New trial
    |
    ER (Estrogen receptor)
    |
    Irene (pyrotinib) • AiRuiKang (dalpiciclib)
    4ms
    The patients reported outcomes of HR-positive HER2-negative advanced breast cancer treated with different CDK4/6 inhibitors (ChiCTR2400081747)
    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
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Verzenio (abemaciclib) • Kisqali (ribociclib) • AiRuiKang (dalpiciclib)
    4ms
    A single arm, multicenter, exploratory clinical study of dalpiciclib combined with chidamide and letrozole in the adjuvant treatment of HR positive and HER2 negative breast cancer (ChiCTR2400081280)
    P4, N=30, Not yet recruiting, An Yang Tumor Hospital; An Yang Tumor Hospital
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    letrozole • Epidaza (chidamide) • AiRuiKang (dalpiciclib)
    4ms
    A multicenter, single-arm, phase II clinical trial of oral CDK4/6 inhibitor dalpiciclib in combination with endocrine therapy in adjuvant treatment for hormone receptor-positive, HER2-negative female breast cancer (ChiCTR2400080962)
    P4, N=317, Not yet recruiting, Dongguan Donghua Hospital; Dongguan Donghua Hospital
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    AiRuiKang (dalpiciclib)
    4ms
    To explore Dalpiciclib plus AI for chemotherapy-insensitive high-risk luminal breast cancer: an single-arm, prospective study (ChiCTR2400085698)
    P2, N=30, Recruiting, Breast Surgery of the First Hospital of China Medical University; The First Affiliated Hospital of China Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    AiRuiKang (dalpiciclib) • goserelin acetate
    4ms
    Dalpiciclib combined with endocrine therapy and concurrent radiotherapy for early HR+/HER2- breast cancer: an exploratory study (ChiCTR2400085859)
    P2, N=50, Recruiting, SHANXI PROVINCIAL CANCER HOSPITAL; SHANXI PROVINCIAL CANCER HOSPITAL
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    AiRuiKang (dalpiciclib)
    4ms
    Comparing efficacy and safety of dalpiciclib in combination with neoadjuvant endocrine therapy versus neoadjuvant chemotherapy in HR-strong-positive and HER2-negative breast cancer patients: a multicenter, open, prospective Phase II study (ChiCTR2400080576)
    P2, N=112, Recruiting, Sun Yat-Sen University Cancer Center; Sun Yat-Sen University Cancer Center
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate • leuprolide acetate for depot suspension
    4ms
    Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • Metastases
    |
    AiRuiKang (dalpiciclib)
    5ms
    Comparative efficacy and safety of CDK4/6 inhibitors combined with endocrine therapies for HR+/HER2-breast cancer: Systematic review and network meta-analysis. (PubMed, Heliyon)
    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.
    Retrospective data • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • AiRuiKang (dalpiciclib)
    7ms
    Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial (clinicaltrials.gov)
    P2, N=32, Recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • Metastases
    |
    Tagrisso (osimertinib) • AiRuiKang (dalpiciclib)
    7ms
    Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=150, Recruiting, Fudan University
    New trial • Real-world evidence • Real-world • Metastases
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • AiRuiKang (dalpiciclib)
    8ms
    Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer (clinicaltrials.gov)
    P2, N=1163, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    fulvestrant • AiRuiKang (dalpiciclib)
    8ms
    Cost-effectiveness comparison of dalpiciclib and abemaciclib combined with an aromatase inhibitor as first-line treatment for HR+/HER2- advanced breast cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res)
    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.
    Journal • HEOR • Cost-effectiveness • Cost effectiveness • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Verzenio (abemaciclib) • letrozole • anastrozole • AiRuiKang (dalpiciclib)
    8ms
    Dalpiciclib in HR+/HER2- ABC (clinicaltrials.gov)
    P=N/A, N=103, Not yet recruiting, RenJi Hospital
    New trial • Real-world evidence • Real-world • Metastases
    |
    AiRuiKang (dalpiciclib)
    8ms
    A pilot trial of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for triple-positive breast cancer. (PubMed, MedComm (2020))
    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.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • letrozole • AiRuiKang (dalpiciclib)
    8ms
    A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=306, Recruiting, Risen (Suzhou) Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • capecitabine • Irene (pyrotinib) • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    9ms
    Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Fudan University | Phase classification: P2 --> P1/2
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • PGR expression
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • fulvestrant • AiRuiKang (dalpiciclib)
    9ms
    Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER) (clinicaltrials.gov)
    P2, N=30, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | N=120 --> 30
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive
    |
    AiRuiKang (dalpiciclib)
    9ms
    Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    everolimus • fulvestrant • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate
    10ms
    Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas (clinicaltrials.gov)
    P1, N=6, Recruiting, West China Hospital
    New P1 trial
    |
    AiRuiKang (dalpiciclib) • Ariely (adebrelimab)
    10ms
    A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=306, Not yet recruiting, Risen (Suzhou) Pharma Tech Co., Ltd.
    New P1/2 trial • Combination therapy • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • capecitabine • Irene (pyrotinib) • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)