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NCT Number: NCT07180056

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Location contact

Wenjin Yin

CONTACT

[email protected]

86(21)68385569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDK4/6 inhibitor

Drug

abemaciclib OR ribociclib

Primary outcomes

  1. Invasive Disease-free Survival (iDFS)

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

    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.

Secondary outcomes

  1. Disease-free Survival (DFS)

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

    Disease-free survival time is defined as the time from date of surgery until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause.

  2. Overall Survival (OS)

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

    Overall survival is defined as the time from surgery to death from any cause.

  3. Adverse events

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

    Adverse events will be assessed according to the NCI CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

Wenjin Yin

Other

Registry information

Official study title

Efficacy and Safety of Adjuvant CDK4/6 Inhibitors in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: a Real-world Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Sep 18, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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