^
4d
CDK4/6 as a Therapeutic Target in HR+/HER2- Breast Cancer Cells-Current Treatment Status. (PubMed, Cancers (Basel))
Moreover, dalpiciclib is being investigated in HR+/HER2- BC treatment. This article will summarize clinical efficacy, recommendations, and differences in toxicity profile between palbociclib, ribociclib, and abemaciclib and will also discuss the possibility of using dalpiciclib in the treatment of breast cancer.
Review • Journal
|
HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4)
|
HER-2 negative
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • AiRuiKang (dalpiciclib)
15d
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer (clinicaltrials.gov)
P1, N=102, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Trial primary completion date: Dec 2024 --> Jun 2025
Trial primary completion date
|
AiRuiKang (dalpiciclib)
20d
Adebrelimab Combined with Dalpiciclib and Standard Endocrine Therapy for HR + / HER2- Breast Cancer (clinicaltrials.gov)
P2, N=30, Recruiting, Harbin Medical University | Not yet recruiting --> Recruiting
Enrollment open
|
AiRuiKang (dalpiciclib) • Ariely (adebrelimab)
2ms
Clinical efficacy and therapy response prediction of neoadjuvant dalpiciclib plus letrozole in postmenopausal patients with HR+/HER2- stage II-III breast cancer (DARLING 01): a single-arm, open-label, exploratory study. (PubMed, Breast Cancer Res)
Dalpiciclib combined with letrozole demonstrated promising antitumor activity and an acceptable safety profile in postmenopausal patients with HR+/HER2- breast cancer. The identification of TFRC, SCUBE2, and MMP11A as predictive biomarkers provides insights into the potential for personalized neoadjuvant treatment strategies.
Journal
|
HER-2 (Human epidermal growth factor receptor 2) • MMP11 (Matrix Metallopeptidase 11) • SCUBE2 (Signal Peptide, CUB Domain And EGF Like Domain Containing 2)
|
HR positive • HER-2 negative • EGFR positive
|
letrozole • AiRuiKang (dalpiciclib)
2ms
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 expression • HER-2 underexpression
|
Aidixi (disitamab vedotin) • exemestane • 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 | Trial primary completion date: Sep 2024 --> Dec 2024
Trial primary completion date
|
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) • tizetatug rezetecan (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, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Feb 2025
Enrollment closed • Trial completion date • Real-world evidence • Real-world • Metastases
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • AiRuiKang (dalpiciclib)
3ms
Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28). (PubMed, Ther Adv Med Oncol)
Palbociclib, abemaciclib, and dalpiciclib demonstrated comparable efficacy in Chinese patients with advanced HR+/HER2- MBC. ClinicalTrials.gov identifier: NCT06344780.
Clinical • Journal • Real-world evidence • Real-world • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • AiRuiKang (dalpiciclib)
3ms
Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
P1/2, N=46, Terminated, Henan Cancer Hospital | Trial completion date: Jan 2026 --> Jul 2024 | Active, not recruiting --> Terminated; Investigators' decision
Trial completion date • Trial termination • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
fulvestrant • AiRuiKang (dalpiciclib) • famitinib (SHR 1020)
4ms
New trial • Metastases
|
albumin-bound paclitaxel • AiRuiKang (dalpiciclib)
4ms
Influence of ethnicity on cyclin-dependent kinase inhibitor efficacy and toxicity: A systematic review and meta-analysis. (PubMed, Breast)
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.
Retrospective data • Review • Journal
|
HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4)
|
HR positive • HER-2 negative • EGFR positive
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • AiRuiKang (dalpiciclib)
5ms
New P2 trial
|
Irene (pyrotinib) • AiRuiKang (dalpiciclib)
5ms
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)
5ms
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)
5ms
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)
5ms
New P2 trial
|
CDK4 (Cyclin-dependent kinase 4)
|
EndoPredict®
|
letrozole • AiRuiKang (dalpiciclib)
6ms
New P3 trial
|
AiRuiKang (dalpiciclib)
6ms
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-A2009 • tizetatug rezetecan (SHR-A1921)
6ms
New P4 trial
|
AiRuiKang (dalpiciclib)
6ms
New P2 trial
|
AiRuiKang (dalpiciclib) • Ariely (adebrelimab)
7ms
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)
7ms
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)
7ms
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)
8ms
New P2 trial • Metastases
|
Epidaza (chidamide) • AiRuiKang (dalpiciclib)
8ms
New P2 trial
|
AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
8ms
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)
8ms
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) • tizetatug rezetecan (SHR-A1921)
8ms
Enrollment change • Real-world evidence • Real-world • Metastases
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • AiRuiKang (dalpiciclib)
8ms
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)
8ms
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
8ms
Enrollment change
|
AiRuiKa (camrelizumab) • AiRuiKang (dalpiciclib)
9ms
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)
9ms
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)
9ms
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)
9ms
New P4 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
AiRuiKang (dalpiciclib)
9ms
New P4 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
letrozole • Epidaza (chidamide) • AiRuiKang (dalpiciclib)
9ms
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
AiRuiKang (dalpiciclib)
9ms
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
9ms
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
9ms
New P2 trial • Metastases
|
AiRuiKang (dalpiciclib)
10ms
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)
12ms
New P2 trial • Metastases
|
Tagrisso (osimertinib) • AiRuiKang (dalpiciclib)