Dalpiciclib in HR+/HER2- ABC

February 1, 2026 updated by: Wenjin Yin, RenJi Hospital

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

To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dalpiciclib
dalpiciclib oral day 1-21, every 28 days
Drug: dalpiciclib
dalpiciclib oral day 1-21, every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)
The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.
From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)
Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.
From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Wenjin Yin, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 2, 2024

First Submitted That Met QC Criteria

March 2, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-022-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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