Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer

Phase 4

Not yet recruiting

• Conditions: Breast Cancer Stage IV
• Interventions: Drug: Inetetamab and Paclitaxel ± Pertuzumab

• Registration Number: NCT06578299
• Lead Sponsor: Fudan University

Brief Summary

This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Study Start: 2024-08-30
• Primary Completion: 2026-03-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Age 18 - 70 years, female
2. Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
3. Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
4. Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
5. Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
6. ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
7. The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
8. Adequate organ function;
9. Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
10. The patient voluntarily signs an informed consent form.

Exclusion Criteria

1. Participated in other clinical trials within 4 weeks;
2. Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
3. During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
4. Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
5. Evidence of central nervous system metastasis or leptomeningeal disease;
6. Individuals with a known history of allergies to the components of this medication regimen;
7. Pregnant or lactating women;
8. Left ventricular ejection fraction<50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;
9. The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inetetamab and Paclitaxel ± Pertuzumab	Inetetamab and Paclitaxel ± Pertuzumab	Inetetamab and Paclitaxel ± Pertuzumab 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. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, 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.

Primary Outcome Measures

Name	Time	Method
PFS	Until progression, assessed up to approximately 24 months	PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Until progression, assessed up to approximately 24 months	ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Clinical Benefit Rate (CBR)	Until progression or death, assessed up to approximately 24 months	Clinical benefit rate was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) or stable disease（SD）\>6 months determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart.
Overall Survival (OS)	Up to approximately 3 years	OS is defined as the time from the participant's first dose of study treatment to the date of death.
Number of Participants With Adverse Events (AEs)	Up to approximately 3 years	Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).