Evaluating the safety of a new chemotherapy regimen for early-stage HER-2-positive breast cancer

To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study

This study is testing a new combination of chemotherapy drugs to see if it's safe and effective for women with early-stage HER2-positive breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shanghai Pudong Hospital (Academic / other)
• Drugs / interventions: chemotherapy, trastuzumab, pertuzumab, cyclophosphamide, doxorubicin
• Locations: 1 site (Shanghai)
• Trial ID: NCT05656079 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the cardiac safety and efficacy of a combination treatment involving pegylated liposomal doxorubicin, cyclophosphamide, trastuzumab, and pertuzumab, followed by docetaxel, in comparison to a standard regimen of epirubicin and cyclophosphamide. The study will involve female participants aged 18-70 with histologically confirmed HER2-positive early-stage breast cancer. Participants will be monitored for cardiac function and overall treatment outcomes to determine the safety of the new regimen in an adjuvant setting.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-70 with confirmed HER2-positive invasive breast cancer who have completed surgery and are starting chemotherapy within 8 weeks.

Not a fit: Patients with known allergies to chemotherapy drugs or those with a history of invasive breast cancer or other malignancies within the last 5 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective chemotherapy option for patients with early-stage HER-2-positive breast cancer.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 18-70 years old, Female;
2. Subjects with histopathologically confirmed invasive breast cancer;
3. HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);
4. No distant metastasis;
5. Lymph node positive or negative, primary tumour≥2cm;
6. Lymph node negative，primary tumour≤2cm and any of the following factors; 1) Histological grade 3; 2) ER negative (\<10%) and PR negative (\<20%); 3) Age\<35 years old; 4) Pathological hint: vascular invasion or intravascular cancer thrombus;
7. Surgery was completed and chemotherapy was started within 8 weeks after surgery;
8. Before and after chemotherapy LVEF≥55%;
9. ECOG performance status of 0-1;
10. Signed the informed consent.

Exclusion Criteria:

1. Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
2. Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma);
3. For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);
4. Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal;
5. Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;
6. Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg;
7. NYHA cardiac insufficiency grading ≥ Ⅲ grade;
8. Severe, uncontrollable systemic disease;
9. Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment;
10. Subjects who participated in other clinical trials at the same time;
11. Subjects determined by the investigator to be inappropriate to participate in this study.

Where this trial is running

Shanghai

• Shanghai Pudong Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yongping Li

Conditions Breast Cancer