Breast CancerNCT07180056
Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer
An observational study of Breast Cancer, run by Wenjin Yin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CDK4/6 inhibitor
- How many people
- 229 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors
Who may be able to join
- 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
Who cannot join
- During pregnancy or lactation
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Wenjin Yin, 86(21)68385569, yinwenjin@renji.com
About this study
Official 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
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
- Being tested
- CDK4/6 inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK4/6 inhibitorDrug
abemaciclib OR ribociclib
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CDK4/6 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of surgery until time of event up to 2 years.
Secondary outcomes (3)
Disease-free Survival (DFS)
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.
Measured: From the date of surgery until time of event up to 2 years
Overall Survival (OS)
Overall survival is defined as the time from surgery to death from any cause.
Measured: From the date of surgery until time of event up to 2 years
Adverse events
Adverse events will be assessed according to the NCI CTCAE v5.0.
Measured: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start28 Aug 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenjin Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, M.D., Principal investigator, Renji Hospital,School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180056
- Sponsor's protocol ID
- LY2025-108-B
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07180056
- Acronym / sponsor ID
- LY2025-108-B
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 229 participants (estimated)
- Lead sponsor
- Wenjin YinUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant CDK4/6 inhibitor | – | Drug: CDK4/6 inhibitorCDK4/6 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- During pregnancy or lactation
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDK4/6 inhibitorabemaciclib OR ribociclib | Drug | Adjuvant CDK4/6 inhibitor |
Primary outcome
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.
3 secondary outcomes
Disease-free Survival (DFS)
Time frame: From the date of surgery until time of event up to 2 years
Overall Survival (OS)
Time frame: From the date of surgery until time of event up to 2 years
Adverse events
Time frame: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjin Yin, M.D. principal investigator
Renji Hospital,School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Wenjin Yin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjin Yin, M.D. (86(21)68385569, yinwenjin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-free Survival (iDFS) (time frame: From the date of surgery until time of event up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.