Adjuvant CDK4/6 inhibitor treatment for HR+/HER2- breast cancer
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
Run by RenJi Hospital · NCT07180056 · Data updated 2026-11-12
This project will test whether taking a CDK4/6 blocker after surgery or other initial therapy helps adults with HR+/HER2- breast cancer stay cancer-free and is safe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 229 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | August 28, 2025 |
| Main results expected | February 2028 |
| Study ends | February 2033 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT07180056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with pathologically confirmed non‑metastatic HR+/HER2‑ breast cancer who meet guideline criteria for adjuvant CDK4/6 therapy and can attend follow‑up at the Shanghai site are ideal candidates.
✕Probably not a fit
People who are pregnant or breastfeeding, have metastatic disease, cannot swallow oral tablets, or have significant gastrointestinal absorption problems are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll adults (≥18) with pathologically confirmed, non‑metastatic HR+/HER2‑ breast cancer who meet guideline recommendations and plan to receive adjuvant CDK4/6 inhibitor therapy. Clinical data including treatment details, adverse events, recurrence, and survival will be collected during routine follow‑up at a single center. Patients who are pregnant, breastfeeding, unable to swallow tablets, or have significant gastrointestinal malabsorption are excluded. The design aims to provide real‑world information on safety, tolerability, and patterns of benefit of adjuvant CDK4/6 use outside randomized trials.
Why it matters
Potential benefit: If successful, this could show that adding a CDK4/6 inhibitor after initial therapy lowers the risk of recurrence and improves outcomes for HR+/HER2‑ patients.
How similar studies have gone: Prior adjuvant trials of CDK4/6 inhibitors have produced mixed results, with some (notably abemaciclib in selected high‑risk patients) showing reduced recurrence while others did not demonstrate clear benefit.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China Recruiting
Study contacts
- Principal investigator: Wenjin Yin, M.D. — Renji Hospital,School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjin Yin, M.D.
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.