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Active, not recruitingNCT06344780Updated Dec 20, 2024

Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer

An observational study in Breast Cancer, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
Female
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Study summary

A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Abemaciclib
  • Palbociclib
  • Dalpiciclib
  • HR Positive
  • HER2 Negative
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 200 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023.

Inclusion criteria

  1. age >= 18 years old;
  2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023;
  3. Received CDK4/6 inhibitors(Abemaciclib, Palbociclib or Dalpiciclib) as first-line therapy for at least one cycle;
  4. Complete medical history was available.

Exclusion criteria

Exclusion Criteria:

  1. Medical history was incomplete.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Abemaciclib cohort
  • Palbociclib cohort
  • Dalpiciclib cohort
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What researchers measure

Primary outcomes

  1. PFS

    Pregression-free survival

    Time frame: 6 weeks

Secondary outcomes

  1. OS

    Overall survival

    Time frame: 6 weeks

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Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06344780
Lead sponsor
Fudan University
Responsible party
Biyun Wang, MD (Professor, Fudan University) — Principal investigator
First posted
Apr 3, 2024
Start date
May 20, 2023
Primary completion
Oct 1, 2024
Completion
Feb 1, 2025 (estimated)
Last update
Dec 20, 2024

Study contacts

Biyun Wang, Professor
principal investigator · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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