Adjuvant CDK4/6 inhibitor treatment for HR+/HER2- breast cancer
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
RenJi Hospital · NCT07180056
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 |
|---|---|
| Enrollment | 229 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07180056 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer