CDK4/6 Inhibitors with Endocrine Therapy for Early Breast Cancer
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
Recruiting
Phase 3Interventional Study
Breast CancerAdjuvant Therapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,903 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer that is hormone receptor positive and HER2 positive. Participants will receive a combination of a new treatment and standard therapy to see if it improves outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18 to 70
I have been diagnosed with HR+/HER2+ breast cancer
I have had surgery for my breast cancer
I completed anti-HER2 targeted therapy within the last year
I have normal function of my major organs
I can use birth control if I can get pregnant
I agree to participate in the trial
You may not be able to join if
I have breast cancer in both breasts
I have cancer that has spread to other parts of my body
I have a history of serious heart problems in the last 6 months
I am currently pregnant or breastfeeding
I have a severe infection
I have active hepatitis B or C
I have a history of drug abuse or psychiatric disorders
I am enrolled in another clinical trial
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.