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

NCT07180056 | Recruiting DMC

• 1 other identifier: LY2025-108-B
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Invasive Disease-free Survival (iDFS)

  Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

  From the date of surgery until time of event up to 2 years.

Secondary Outcomes (3)

• Disease-free Survival (DFS)

  From the date of surgery until time of event up to 2 years

• Overall Survival (OS)

  From the date of surgery until time of event up to 2 years

• Adverse events

  From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years)

Study Arms (1)

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.

Drug: CDK4/6 inhibitor

Interventions

CDK4/6 inhibitor DRUG

abemaciclib OR ribociclib

Adjuvant CDK4/6 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors

You may qualify if:

• 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

You may not qualify if:

• During pregnancy or lactation
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption

Sponsors & Collaborators

• Wenjin Yin: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

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

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2033
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)