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

NCT ID: NCT06344780

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-20

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Abemaciclib Palbociclib Dalpiciclib HR Positive HER2 Negative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Abemaciclib cohort

No interventions assigned to this group

Palbociclib cohort

No interventions assigned to this group

Dalpiciclib cohort

No interventions assigned to this group

Eligibility Criteria

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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

1\. Medical history was incomplete.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Biyun Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Chen Y, Xie Y, Sang D, Xie N, Han X, Zhao Y, Li J, Yue J, Yuan P, Wang B. Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28). Ther Adv Med Oncol. 2024 Dec 17;16:17588359241302018. doi: 10.1177/17588359241302018. eCollection 2024.

Reference Type DERIVED
PMID: 39697620 (View on PubMed)

Other Identifiers

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YOUNGBC-28

Identifier Type: -

Identifier Source: org_study_id