A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized, controlled, open, phase III trial of adjuvant intensive therapy for early breast cancer with HR+/ HER2-SNF4 based on SNF molecular typing. A randomized, controlled, open Phase III study to explore the efficacy and safety of Apatinib combined with standard endocrine therapy in adjuvant intensive therapy for HR+/ HER2-SNF4 type early high-risk breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Women aged ≥18 years and ≤70 years;

2. Histologically confirmed HR+/HER2- invasive breast cancer (defined by immunohistochemical detection of ER > 10% positive tumor cells were defined as ER positive, PR > 10% positive tumor cells were defined as positive PR, and ER and/or PR were defined as positive HR. HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);

3. Definition of SNF4 subtype: SNF4 subtype confirmed by digital pathology of H&E sections;

4. High-risk early breast cancer, which was pathologically confirmed as HR+/HER2- and SNF4 subtypes; pT2-4N0-3M0;

5. Complete the adjuvant chemotherapy selected by the doctor;

6. No more than 16 months from surgery to randomization, and no more than 12 weeks after non-endocrine therapy;

7. The functions of major organs are basically normal, meeting the following conditions:

1. The standard of blood routine examination shall meet: HB ≥90 g/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×ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);

8. ECOG score 0 or 1;

9. Fertile female subjects are required to use a medically approved contraceptive for the duration of the study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. bilateral breast cancer;

2. A history of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;

3. transfer of any part;

4. Pregnant or lactating women, women of childbearing age can not effectively contraceptive;

5. Patients participating in other clinical trials;

6. Severe organ dysfunction (heart, lung, liver and kidney); 50% (cardiac hypertrophy); Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, myocardial infarction, or cerebrovascular accident) within 6 months before randomization; Diabetics with poor blood sugar control;

7. Patients with a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), shall not be included in the group; If fecal occult blood (+), gastroscopy is required;

8. Abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days before the study;

9. Urine routine showed urine protein ≥++ or confirmed 24 hours urine protein quantity > 1.0g;

10. Patients with hypertension who cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg).

11. Allergic constitution, or known allergic history of the drug components of the program;

12. Previous thyroid dysfunction;

13. Severe or uncontrolled infection;

14. Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders; The researchers determined that the patients were not suitable for the study.