Combining Apatinib with CDK4/6 inhibitors for advanced HR+/HER2- breast cancer treatment
Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)
This study is testing if adding Apatinib to standard hormone therapy can help people with advanced HR+/HER2- breast cancer feel better and have better treatment results.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, Apatinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06447623 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the effectiveness and safety of Apatinib when used alongside standard first-line endocrine therapy in patients with HR+/HER2- SNF4 subtype advanced breast cancer. The study is randomized and controlled, aiming to determine if this combination can improve treatment outcomes compared to standard therapies alone. Participants will receive Apatinib, a CDK4/6 inhibitor, and either an aromatase inhibitor or Fulvestrant. The trial focuses on patients who have not received prior treatment for their advanced condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed HR+/HER2- breast cancer of the SNF4 subtype and no prior treatment for advanced disease.
Not a fit: Patients with HER2-positive breast cancer or those who have previously received treatment for advanced breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a more effective option for patients with advanced HR+/HER2- breast cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies in breast cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Inclusion Criteria:
* Patients need to meet all of the following conditions
* Patients must be ≥18 and ≤ 75 years of age;
* Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER \>10%, or/and PR\>10%, HER 0 OR +, if HER2++, FISH negative);
* SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections;
* Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended);
* No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
* Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;
* The functions of the main organs are basically normal, and the following conditions are met:
1. Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
2. Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula);
* ECOG performance status 0 or 1; The expected survival is more than 3 months;
* Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
* Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.
Exclusion Criteria:
* Patients with any of the following conditions were excluded from the study
* Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
* A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
* Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.
* Pregnant or lactating patients;
* Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;
* Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\'s participation in the study;
* Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
* The investigator does not consider the patient suitable for participation in any other circumstances of the study.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhimin Shao, MD, PhD
- Email: zhimingshao@yahoo.com
- Phone: 86-021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.