Dalpiciclib for HR-positive, HER2-negative advanced breast cancer
Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study
This study tests whether dalpiciclib is safe and helps people with hormone receptor–positive, HER2‑negative advanced breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06301438 on ClinicalTrials.gov |
What this trial studies
This is an observational study of dalpiciclib given to patients with histologically confirmed HR‑positive, HER2‑negative advanced breast cancer and good performance status (ECOG 0–1). Patients receiving dalpiciclib will be followed for safety outcomes and measures of disease control such as tumor response and progression. The trial is conducted at RenJi Hospital, School of Medicine, Shanghai Jiao Tong University and uses routine clinical visits and imaging to collect data. No randomized comparison is described, so results will reflect real‑world experience with this agent in the enrolled population.
Who should consider this trial
Good fit: Adults with histologically confirmed advanced breast cancer that is hormone receptor–positive and HER2‑negative with ECOG performance status 0–1 are the intended participants.
Not a fit: Patients with HER2‑positive disease, poor performance status (ECOG >1), pregnancy or breastfeeding, or significant immunodeficiency are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, dalpiciclib could provide another oral treatment option that helps delay disease progression and control symptoms in this patient group.
How similar studies have performed: Other CDK4/6 inhibitors have demonstrated clear benefit for HR+/HER2‑negative advanced breast cancer, and dalpiciclib is a similar agent with limited but promising early clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed advanced breast cancer * Hormone receptor-positive and human epidermal growth factor receptor 2-negative * ECOG 0-1 Exclusion Criteria: * Pregnant or breastfeeding * History of immunodeficiency
Where this trial is running
Shanghai
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Wenjin Yin — Renji Hospital, School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjin Yin
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.