CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females aged ≥18 and ≤70 years.
ECOG systemic status grade 0 to 1.
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.
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
Disqualifiers
Bilateral breast cancer;
Metastasis to any site;
Taking food or medications that are strong inhibitors or inducers of CYP3/4.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
DrugStandard endocrine therapy
Standard endocrine therapy combined with CDK4/6 Inhibitor
DrugCDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy
Treatment groups
1,903 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
5-years Invasive disease free survival
5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.
Time frame
5 yearsSecondary outcomes
1
Distant Recurrence-Free Survival (DRFS)
DRFS is defined as the time interval from the start of cancer treatment to the first occurrence of distant metastasis or death from any cause.
Time frame
5 years2
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame
Approximately 5 years3
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.
Time frame
Up to approximately 3 years4
Patient-Reported Outcome (PRO)
Patient-Reported Outcome (PRO) refers to a report that comes directly from the patient on her health status, functional status, and experience of treatment, without interpretation by healthcare or other personnel (e.g., symptoms, quality of life, physical functioning, etc.), and is usually collected through standardized questionnaires or scales. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.
Time frame
Up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov