Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer

NCT06537674 | Not Yet Recruiting FDA Drug

• 1 other identifier: OBU-BC-II-184
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer

Conditions

HER2+ Breast Cancer

Outcome Measures

Primary Outcomes (1)

• EORTC QLQ-C30 scale score

  PRO scale scores between two groups collected at different time points

  through study completion, an average of 1 year

Secondary Outcomes (1)

• tpCR

  1-2 weeks after surgery

Study Arms (2)

Group A

The patient received six cycles of neoadjuvant therapy (pyrotinib and trastuzumab purplitol and platinum-based drugs) and underwent radical mastectomy (breast-conserving surgery or total mastectomy) after treatment. After the operation, the doctor will give the corresponding treatment according to the results of the postoperative medical examination

Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection

Group B

The patient went on to complete six cycles of neoadjuvant therapy (pyrotinib and trastuzumab) and underwent radical mastectomy (breast-conserving surgery or total mastectomy) after treatment. After the operation, the doctor will give the corresponding treatment according to the results of the postoperative medical examination

Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection

Interventions

Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection DRUG

Group A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2-positive early stage breast cancer patients

You may qualify if:

• Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
• Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);
• Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
• ECOG score 0-1;
• Plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
• If the major organs function normally, the following criteria are met:
• (1) The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: TBIL≤ upper limit of normal value (ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized, they should consent to abstinence or use an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment.
• \. Volunteer to join the study and sign the informed consent.

You may not qualify if:

• Known allergic history of the drug components of this protocol;
• Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
• Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
• Stage IV (metastatic) breast cancer patients;
• Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
• Serious heart disease or discomfort that cannot be treated;
• Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
• Pregnant or lactating women;
• Patients with severe liver and kidney function diseases and blood system diseases;

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 5, 2024
• Study Start: August 15, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-08