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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | endocrine therapy |
|
| Experimental | Experimental | Standard endocrine therapy combined with CDK4/6i |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) | Drug | Standard endocrine therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
Bilateral breast cancer;
Metastasis to any site;
Taking food or medications that are strong inhibitors or inducers of CYP3/4.
History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao, MD, PhD | Contact | +86-021-64175590 | zhi_ming_shao@163.com | |
| min he | Contact | zhi_ming_shao@163.com |
| Name | Affiliation | Role |
|---|---|---|
| zhimin shao | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan cancer center | Recruiting | Shanghai | China |
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| Standard endocrine therapy combined with CDK4/6 Inhibitor | Drug | CDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy |
|
OS is defined as the time from randomisation until the date of death due to any cause.
| Approximately 5 years |
| 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. | Up to approximately 3 years |
| 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. | Up to approximately 3 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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