Adding a CDK4/6 blocker to hormone treatment after surgery for high-risk HR+/HER2+ early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, randomized Phase III trial comparing standard adjuvant endocrine therapy alone versus endocrine therapy combined with a CDK4/6 inhibitor. It enrolls women 18–70 with histologically confirmed HR+/HER2+ early breast cancer at high risk (≥pN1 after surgery, residual disease after neoadjuvant therapy, or pre-treatment cT4/N3), within one year of completing anti-HER2 therapy. Participants receive standard endocrine options (tamoxifen or anastrozole/letrozole/exemestane) with or without an oral CDK4/6 inhibitor and are followed for safety and cancer outcomes. The trial is designed to see if adding CDK4/6 inhibition reduces recurrence compared with endocrine therapy alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Females aged ≥18 and ≤70 years.
2. ECOG systemic status grade 0 to 1.
3. Histologically confirmed invasive HR+/HER2+ breast cancer (Specific definition: breast cancer patients whose estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2) are all determined to be positive by pathologic testing. Specifically: ER positive: IHC\>10%, PR positive: IHC\>10%, HER2 positive: IHC+++ or IHC++ but amplified by FISH.
4. Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN1 ; or postoperative pathology suggestive of non-pCR after neoadjuvant therapy; or postoperative pathology suggestive of pCR after neoadjuvant therapy but with clinical staging consistent with cT4 or N3 before neoadjuvant therapy
5. Within 1 year of completion of adjuvant anti-HER2 targeted therapy: anti-HER2 targeted therapy includes trastuzumab-based therapy, and/or T-DM1 therapy, and/or TKI therapy.
6. The function of major organs is basically normal, and the following conditions are met: ① The criteria for routine blood tests need to be met: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L; ② The biochemical tests need to be met as follows: TBIL ≤ 1.5 × ULN (the upper limit of normal value); ALT and AST ≤ 3 × ULN; serum Cr ≤ 1 × ULN, and endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula).
7. Female subjects of childbearing potential are required to use a medically approved form of contraception during study treatment, and for at least 3 months after the last dose of study drug.
8. Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up visits.

Exclusion Criteria:

1. Bilateral breast cancer;
2. Metastasis to any site;
3. Taking food or medications that are strong inhibitors or inducers of CYP3/4.

   1. Strong inhibitors of CYP3/4 include: boceprevir, clarithromycin, konifactam, delavirdine, indinavir, itraconazole, ketoconazole, ritonavir, mibefradil, miconazole, fazodone, nelfinavir, propoxiconazole, ritonavir, saquinavir, naloxone, telaprevir, telithromycin, voriconazole, grapefruit, grapefruit juice, or grapefruit containing foods.
   2. Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
4. History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
5. other malignancy within the previous 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
6. Pregnant or lactating women, women of childbearing age who are unable to use effective contraception;
7. Patients who are concurrently enrolled in other clinical trials;
8. severe or uncontrolled infection;
9. Patients with known active HBV or HCV infection or Hepatitis B DNA ≥500, or chronic stage with abnormal liver function;
10. Those with a history of psychotropic substance abuse that cannot be stopped or those with psychiatric disorders;
11. Patients who, in the judgment of the investigator, are not suitable for participation in this study.

Where it's running

• Fudan cancer center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: zhimin shao — Fudan University
• Study coordinator: Zhimin Shao, MD, PhD
• Email: zhi_ming_shao@163.com
• Phone: +86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.