AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Neoadjuvant Dalpiciclib Plus Letrozole Versus Standard Chemotherapy in High-Risk HR+/HER2- Negative Breast Cancer (DARLING-02): A Randomized Phase II Trial (SABCS 2025) - "Abstract is embargoed at this time."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Dalpiciclib Plus Pyrotinib Plus Letrozole for Patients with Estrogen Receptor-Positive and HER2-Positive Metastatic Breast Cancer (DAPLET) (SABCS 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Neoadjuvant pyrotinib, trastuzumab, dalpiciclib, and exemestane in triple-positive breast cancer: a multicenter phase II trial (SABCS 2025) - "Abstract is embargoed at this time."

Clinical • P2 data • Breast Cancer • Oncology • Solid Tumor

Dalpiciclib Combined with Letrozole as Neoadjuvant Therapy for Stage II-III HR-Positive, HER2-Negative Breast Cancer: A Phase II Study (SABCS 2025) - "Abstract is embargoed at this time."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

An Exploratory Clinical Trial of CDK4/6 Inhibitor Dalpiciclib Combined with Aromatase Inhibitors as Neoadjuvant Therapy for Stage II-III HR-positive HER2-negative Breast Cancer (SABCS 2025) - "Abstract is embargoed at this time."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Clinical Study of Fluzoparib Combined with Dalpiciclib and Endocrine Neoadjuvant Therapy for gBRCA-Mutated HR+/HER2- Early-Stage Breast Cancer (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Harbin Medical University Affiliated Cancer Hospital; Harbin Medical University Affiliated Cancer Hospital

New trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2

An Exploratory Study of Concurrent or Sequential Radiotherapy Combined with Dalpiciclib plus Endocrine Therapy in Early-Stage or Locoregionally Advanced Hormone Receptor-Positive/HER2-Negative Breast Cancer (ChiCTR) - P2 | N=200 | Not yet recruiting | Sponsor: Shanxi Cancer Hospital; Shanxi Cancer Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Single arm, multicenter, exploratory phase II clinical study of new adjuvant therapy with Trastuzumab Deruxtecan for Injection for injection for early or locally advanced HR positive/HER2 low expression breast cancer with poor efficacy of dalpiciclib combined with endocrine therapy (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Anyang Tumor Hospital; Anyang Tumor Hospital

New P4 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Efficacy and safety of Dalpiciclib in combination with endocrine adjuvant therapy for middle/high-risk HR-positive early stage breast cancer: a multicenter, prospective clinical study (ChiCTR) - P4 | N=2000 | Recruiting | Sponsor: Jilin Cancer Hospital; Jilin Cancer Hospital

New P4 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Letter to the editor--efficacy and Safety of Neoadjuvant Treatment of Trastuzumab and Pyrotinib Plus Dalpiciclib in HR-negative/HER2-positive Breast Cancer an Exploratory, Open-label Phase II Study. (PubMed, Int J Surg) - No abstract available

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of JS105, a selective inhibitor of mutant PI3Kα, in patients with advanced cancer (ESMO 2025) - P1, P1/2 | "The combination therapy study enrolled patients with HR-positive, HER2-negative advanced breast cancer to receive JS105 150 to 250 mg in combination with dalpiciclib and fulvestrant for a 28-day cycle. Among the 23 patients with PIK3CA mutations, the ORR and DCR were 39.1% and 87.0% (Table). Table: 466P The best overall response of two studies (Based on investigator assessment per RECIST 1.1) Monotherapy Study Combination Therapy Study Evaluable patients with PIK3CA mutation and measurable lesions, n 32 23 Best Overall Response, n (%) Complete Response (CR) 0 0 Partial Response (PR) 9 (28.1) 9 (39.1) Stable Disease (SD) 19 (59.4) 11 (47.8) Progressive Disease (PD) 4 (12.5) 3 (13.0) Objective Response Rate (ORR), %, (95% CI) 28.1 (13.7, 46.7) 39.1 (19.7, 61.5) Disease Control Rate (DCR), %, (95% CI) 87.5 (71.0, 96.5) 87.0 (66.4, 97.2) Conclusions JS105 monotherapy or combination therapy demonstrated a favorable safety profile and promising efficacy in patients..."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Pyrotinib combined with dalpiciclib in the treatment of refractory advanced HER2 positive gastric cancer or solid tumors: safety and efficacy results from a phase Id trial (ESMO Asia 2025) - No abstract available

Clinical • Metastases • Gastric Cancer • Oncology • Solid Tumor • HER-2

Matching-adjusted indirect comparison of bireociclib plus fulvestrant versus dalpiciclib Plus fulvestrant as second-line treatment of HR+/HER2- advanced breast cancer (ABC) (ESMO 2025) - P3 | "Conclusions This MAIC analysis suggests comparable efficacy between bireociclib and dalpiciclib when combined with fulvestrant in HR+/HER2- ABC patients who progressed on or after prior endocrine therapy. The two agents display distinct safety profiles, with dalpiciclib showing more severe hematological toxicities and bireociclib exhibiting more gastrointestinal adverse events."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

DALPICICLIB COMBINED WITH NONSTEROIDAL AROMATASE INHIBITORS IN ESTROGEN RECEPTOR-POSITIVE RECURRENT/METASTATIC OVARIAN CANCER AND UTERINE NEOPLASMS: UPDATED RESULTS FROM A SINGLE-CENTER, SINGLE-ARM TRIAL (IGCS 2025) - P2 | "As the data cutoff (Apr. 17th, 2025), 30 pts with a median of one prior therapy for advanced disease were enrolled, including 9 with low-grade serous ovarian carcinoma (LGSOC), 12 with uterine EC, 8 with low-grade endometrial stromal sarcoma (LGESS) and 1 with uterine leiomyosarcoma (LMS). Twenty-five pts had received ≥1 efficacy assessment, and 76.0% achieved 12wPFS."

Clinical • Metastases • Endometrial Cancer • Leiomyosarcoma • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Sarcoma • Solid Tumor • Uterine Cancer • Uterine Leiomyosarcoma • ER

Real-world study on the efficacy and safety of Dalpiciclib in elderly patients with HR-positive, HER2-negative advanced breast cancer in the Xinjiang region [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer: Three-year outcomes from the MUKDEN 01 study (ESMO 2025) - P2 | "Conclusions The MUKDEN 01 trial supports a potential de-escalation neoadjuvant regimen for TPBC. Long-term follow-up is underway to further assess outcomes."

Clinical • Breast Cancer • Oncology • Solid Tumor

Efficacy and safety of dalpiciclib combined with endocrine therapy after progression on prior CDK4/6 inhibitors in HR+/HER2- advanced breast cancer (ESMO 2025) - "Subgroups including those without liver metastases, with secondary endocrine resistance, and receiving sequential CDK4/6i therapy appear to derive greater benefit. Legal entity responsible for the study The authors."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of mecapegfilgrastim for prophylaxis of dalpiciclib -induced neutropenia in patients with advanced HR+/HER2- breast cancer: a multicenter, open-label, randomized controlled phase II trial (ESMO Asia 2025) - No abstract available

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy, Safety, and Biomarkers of Neoadjuvant Dalpiciclib (CDK4/6 inhibitor) plus Aromatase Inhibitors in Operable HER2-Negative Luminal B Breast Cancer: A Prospective, Single-Center, Single-Arm, Phase II Trial (DANCER). (PubMed, MedComm (2020)) - P2 | "A novel baseline response index combining CCL4 and pRb showed excellent predictive performance and stratified patients by likelihood of clinical benefit, with ctDNA dynamics further refining stratification. These findings support DAL-AI as a promising neoadjuvant option and highlight the value of biomarker-guided strategies for treatment optimization."

Biomarker • Journal • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • CCL19 • GSTM1 • HER-2

A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov) - P3 | N=312 | Not yet recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.

New P3 trial • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy (clinicaltrials.gov) - P1/2 | N=33 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Case Report: Synchronous cervical, gastric and rectal metastases in occult breast cancer. (PubMed, Front Oncol) - "Following six months of treatment with letrozole (1mg/day) in combination with dalpiciclib the patient demonstrated significant symptomatic relief, with remarkable reduction in the lesions located in the cervix, stomach, and rectum. This case represents the first documented instance of occult primary breast cancer with simultaneous metastases to the cervix, stomach, and rectum."

Journal • Breast Cancer • Oncology • Solid Tumor

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study (clinicaltrials.gov) - P2 | N=288 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Dalpiciclib Plus fulvestrant and pyrotinib in HR+/HER2-low advanced breast cancer after progression on CDK4/6 Inhibition (DapPLE-HER): a bayesian optimal phase II study. (PubMed, Int J Surg) - "The combination of dalpiciclib, fulvestrant, and pyrotinib demonstrated modest efficacy with a manageable safety profile in HR +/HER2-low advanced BC patients who had progressed on prior CDK4/6 inhibitor therapy. This novel regimen demonstrated exploratory efficacy and a favorable safety profile, warranting further validation in future randomized controlled studies."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2