The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer

NCT06641544 | Recruiting Phase 4

• 1 other identifier: 2024-SSKY-012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart

  Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Tumor assessments every 6 weeks from randomization to radiographical PD or death from any cause, whichever occurred first，up to the primary completion date (up to 2 years)

• Clinical Benefit Rate (CBR)

  Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)

• Number of Adverse Events using NCI CTCAE 5.0 [Safety and Tolerability]

  From signing the informed consent to 30 days after last dose

• Overall survival（OS）

  From date of the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause，assessed up to about 48 months.

• Duration of Respons（DoR）

  Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)

Study Arms (2)

A Group

ACTIVE COMPARATOR

Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Chemotherapy regimen chosen by the physician

Drug: Inetetamab

B Group

EXPERIMENTAL

Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pyrotinib：400 mg once daily orally within 30 minutes after a meal at the same time each day. Chemotherapy regimen chosen by the physician

Drug: Inetetamab

Interventions

Inetetamab DRUG

Group A received Inetetamab+Pertuzumab+TPC, while Group B received Inetetamab+Pyrotinib+TPC.

Also known as: Pertuzumab，Pyrotinib

A Group; B Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥ 18 years and ≤ 70 years old;
• Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive);
• Invasive breast cancer confirmed by pathological examination, with evidence of local recurrence or imaging metastasis, and those with local recurrence must be confirmed by the researcher as unable to undergo radical surgery;
• Have not received first-line anti-HER2 treatment or (new) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months;
• ECOG PS score 0-2, expected survival period ≥ 6 months, and able to follow up;
• According to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there must be at least one clearly measurable and/or assessable lesion present, and the lesion diameter evaluated by CT or MRI must be ≥ 1cm;
• In the absence of blood transfusion or pharmacological treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to the first treatment, and organ function must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; platelets (PLT) ≥ 90×10\^9/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN,known as Gilbert syndrome patients, TBIL ≤ 2 × ULN; ALT and AST ≤2.5×ULN; and liver metastasis patients require ALT and AST ≤5×ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤1.5×ULN;
• Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal, unless drugs known to alter INR and APTT are used;
• Left ventricular ejection fraction (LVEF) ≥50%;
• lead electrocardiogram: Fridericia corrected QT interval (QTcF)\<470msec;
• No history of major organs such as the heart, lungs, liver, kidneys, or endocrine system;
• Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures;
• Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

You may not qualify if:

• Have received other clinical study drugs within 4 weeks prior to the first study drug administration;
• Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
• During the (new) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab, pertuzumab, and pyrotinib;
• Patients who experience disease progression during (new) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (new) adjuvant system treatment;
• Evidence of symptomatic central nervous system metastasis or leptomeningeal disease (patients with brain metastases who have received radiation therapy and have been stable for ≥ 4 weeks can be enrolled);
• Patients with only bone or skin as the sole target lesion;
• Serious heart disease or discomfort, including but not limited to the following situations:
• History of heart failure or systolic dysfunction (LVEF\<50%);
• High risk or treatable angina pectoris or arrhythmia (such as second degree type 2 atrioventricular block or third degree atrioventricular block, ventricular tachycardia);
• Clinically significant heart valve disease;
• Electrocardiogram indicates transmural myocardial infarction;
• Uncontrolled hypertension (excluding stable cases where systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>90 mmHg can be controlled after stable treatment);
• Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers);
• Presence of active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV RNA above the upper limit of normal range), and cirrhosis;
• History of immunodeficiency, including HIV infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat sen Memorial Hospital of Sun Yat sen University Shenzhen Shantou Central Hospital

Shanwei, Guangdong, 516621, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jianli Zhao, Doctor

CONTACT

15920589334; zhaojli5@mail.sysu.edu.cn

Ying Wang, Doctor

CONTACT

13925038181; yingwang1101@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)