NCT06301438

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
May 2024Dec 2028

First Submitted

Initial submission to the registry

March 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

March 2, 2024

Last Update Submit

February 1, 2026

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

    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 Outcomes (1)

  • Adverse events

    From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)

Study Arms (1)

dalpiciclib

dalpiciclib oral day 1-21, every 28 days

Drug: dalpiciclib

Interventions

dalpiciclibDRUG

dalpiciclib oral day 1-21, every 28 days

dalpiciclib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Histologically confirmed advanced breast cancer
  • Hormone receptor-positive and human epidermal growth factor receptor 2-negative
  • ECOG 0-1

You may not qualify if:

  • Pregnant or breastfeeding
  • History of immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

dalpiciclib

Study Officials

  • Wenjin Yin

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin

CONTACT

86(21)68385569yinwenjin@renji.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of Breast Surgery Department

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 8, 2024

Study Start

May 3, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)