OncoMatch/Clinical Trials/NCT07019363
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
Is NCT07019363 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Standard endocrine therapy combined with CDK4/6 Inhibitor for breast cancer.
Treatment: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) · Standard endocrine therapy combined with CDK4/6 Inhibitor — This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (IHC >10%)
ER positive: IHC>10%
Required: PR (PGR) overexpression (IHC >10%)
PR positive: IHC>10%
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with FISH amplification)
HER2 positive: IHC+++ or IHC++ but amplified by FISH
Disease stage
Excluded: Stage METASTASIS TO ANY SITE
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-HER2 targeted therapy (trastuzumab-based therapy, T-DM1 therapy, TKI therapy) — adjuvant
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.
Lab requirements
Blood counts
hb ≥ 90g/l (no blood transfusion within 14 days); anc ≥ 1.5 × 109/l; plt ≥ 75 × 109/l
Kidney function
serum cr ≤ 1 × uln, and endogenous creatinine clearance > 50 ml/min (cockcroft-gault formula)
Liver function
tbil ≤ 1.5 × uln; alt and ast ≤ 3 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07019363 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-HER2 targeted therapy.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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