Combining Darsilide with Trastuzumab and Patuzumab for Breast Cancer Treatment

A Clinical Study of Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR Positive HER2 Positive Breast Cancer

This study is testing if a new treatment combining Darsilide with two other drugs can help women with early or locally advanced HER2-positive breast cancer before they have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: immunotherapy, radiation, Trastuzumab, Patuzumab, pertuzumab
• Locations: 1 site (Henan, Henan)
• Trial ID: NCT06276868 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-arm, prospective study aimed at evaluating the efficacy and safety of Darsilide combined with endocrine therapy, Trastuzumab, and Patuzumab in treating early or locally advanced HER2-positive breast cancer before surgery. Participants will receive a specific treatment regimen that includes Darsilide, Letrozole, and the HER2-targeted therapies Trastuzumab and Patuzumab over multiple cycles. The primary goal is to assess the pathologic complete response (pCR) rate after neoadjuvant therapy, monitored through breast MRI evaluations.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 to 70 with HR-positive, HER2-positive invasive breast cancer at stages II to IIIA.

Not a fit: Patients with non-invasive breast cancer or those who do not meet the specified health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the effectiveness of neoadjuvant therapy for patients with HER2-positive breast cancer, potentially leading to better surgical outcomes.

How similar studies have performed: While this approach is innovative, similar studies combining targeted therapies have shown promising results in improving treatment outcomes for HER2-positive breast cancer.

Eligibility criteria

Inclusion Criteria:

1. Female initial treatment patients aged ≥ 18 years and ≤ 70 years.
2. ECOG score 0-1 points.
3. Pathologically confirmed as invasive breast cancer, with tumor staging of II-IIIA.
4. HR positive HER-2 positive.
5. The main organs function normally and meet the following standards:

（1）The blood routine examination standards must comply with:ANC ≥1.5×10 9/L；PLT ≥100×109/L；Hb ≥90g/L. （2）Biochemical examination must meet the following standards: TBIL ≤ 1.5 Upper limit of normal value (ULN)；ALT and AST ≤ 1.5 times the upper limit of normal value (ULN)；Alkaline phosphatase ≤ 2.5 times the upper limit of normal value (ULN)；BUN and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min； （3）Cardiac ultrasound and echocardiography: Left ventricular ejection fraction (LVEF ≥ 50%).

6\. For female patients who have not undergone menopause or surgical sterilization: Agree to abstain or use effective contraceptive methods during the treatment period and at least 7 months after the last administration during the study treatment.

7\. Volunteer to join this study and sign an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer.
2. inflammatory breast cancer.
3. Previously received anti-tumor therapy or radiation therapy for any malignant tumor, excluding cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma.
4. Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy.
5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
6. Individuals who have previously suffered from clinically significant lung diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation changes that do not require corrective treatment), or those who have been found to have such diseases through screening period examinations.
7. Serious heart disease or discomfort, including but not limited to the following diseases:

（1）Confirmed history of heart failure or systolic dysfunction (LVEF\<50%). （2）High risk uncontrolled arrhythmia（atrial tachycardia，ventricular tachycardia，Higher level atrioventricular block）； （3）Angina pectoris requiring treatment with anti angina drugs； （4）Clinically significant heart valve disease； （5）ECG shows transmural myocardial infarction； （6）Poor control of hypertension (systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>100 mmHg)； 8. Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption.

9\. Individuals with a known history of allergies to the drug components of this protocol；Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

10\. Pregnant and lactating female patients, those with fertility and positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication.

11\. Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other situation where the researcher deems the patient unsuitable to participate in this study.

Where this trial is running

Henan, Henan

• Henan cacer hospital — Henan, Henan, China (Recruiting)

Study contacts

• Principal investigator: Zhenzhen Liu — Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu

Conditions Breast Cancer; HER2-positive Breast Cancer; pathologic complete response; Dalcelli; objective response rate; Disease-free survival