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New treatment option for Breast Cancer
Official title CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
ClinicalTrials.gov ID: NCT07019363
What this study is testing
What is Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)?
Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
- Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN1 ; or postoperative pathology...
- Within 1 year of completion of adjuvant anti-HER2 targeted therapy: anti-HER2 targeted therapy includes trastuzumab-based therapy, and/or T-DM1...
You likely can't join if
- 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...
- Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
- History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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 ≥...
- Female people 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.
- people voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up visits.
- 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...
- Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
- History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- 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;
- Pregnant or lactating women, women of childbearing age who are unable to use effective contraception;
- Patients who are concurrently enrolled in other clinical trials;
- severe or uncontrolled infection;
- Patients with known active HBV or HCV infection or Hepatitis B DNA ≥500, or chronic stage with abnormal liver function;
- Those with a history of psychotropic substance abuse that cannot be stopped or those with psychiatric disorders;
- Patients who, in the judgment of the investigator, are not suitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.