Clinical trial Recruiting at 1 site Observational Ages 18 and up

Dalpiciclib for HR-positive, HER2-negative advanced breast cancer

Official title: Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study

Run by RenJi Hospital · NCT06301438 · Data updated 2026-11-12

This study tests whether dalpiciclib is safe and helps people with hormone receptor–positive, HER2‑negative advanced breast cancer.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment103 (estimated)
SponsorRenJi Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedMay 3, 2024
Main results expectedJanuary 2027
Study endsDecember 2028
Registry record updatedFebruary 3, 2026
Trial IDNCT06301438 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.