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

An Exploratory Clinical Study of the PRO of Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: HER2+ Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection

• Study Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

HER2-positive early stage breast cancer patients

Description

Inclusion Criteria:

1. Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
2. Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);
3. 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);
4. ECOG score 0-1;
5. 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);
6. 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.

8. Volunteer to join the study and sign the informed consent.

Exclusion Criteria:

1. Known allergic history of the drug components of this protocol;
2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
4. Stage IV (metastatic) breast cancer patients;
5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
6. Serious heart disease or discomfort that cannot be treated;
7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
8. Pregnant or lactating women;
9. Patients with severe liver and kidney function diseases and blood system diseases;
10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Poor compliance and refusal to cooperate with treatment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 A is Trastuzumab intravenous drip,Group B is 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; Group A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
tpCR	total pathological complete response	1-2 weeks after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: OBU-BC-II-184

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No