Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer

NCT ID: NCT07180056

Last Updated: 2025-11-19

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

RECRUITING

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-28

Study Completion Date

2033-02-28

Brief Summary

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To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adjuvant CDK4/6 inhibitor

CDK4/6 inhibitors are drugs that block cell division in cancer cells. They are used with hormonal therapy for hormone receptor-positive breast cancer and may improve survival.

CDK4/6 inhibitor

Intervention Type DRUG

abemaciclib OR ribociclib

Interventions

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CDK4/6 inhibitor

abemaciclib OR ribociclib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged ≥18 and older
* Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence
* HR+/HER2-
* ECOG 0-3
* Subjects meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors

Exclusion Criteria

* During pregnancy or lactation
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenjin Yin

OTHER

Sponsor Role lead

Responsible Party

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Wenjin Yin

Deputy Chief of Breast Surgery Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenjin Yin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital,School of Medicine, Shanghai Jiaotong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjin Yin, M.D.

Role: CONTACT

86(21)68385569

Facility Contacts

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Wenjin Yin

Role: primary

86(21)68385569

Other Identifiers

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LY2025-108-B

Identifier Type: -

Identifier Source: org_study_id

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