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Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer | Clinical Trials | Clareo Health

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

The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）

NCT06578299•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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.

Key Dates

Start Date

August 30, 2024

Primary Completion Date

March 30, 2026

Completion Date

August 30, 2027

Last Updated

August 29, 2024

Enrollment

100

ESTIMATED participants

Conditions

Breast Cancer Stage IV

Interventions

Inetetamab and Paclitaxel ± Pertuzumab

DRUG

Contacts

Jian Zhang, MD,PhD

CONTACT

+8664175590 syner2000@163.com

Yanchun Meng

CONTACT

+8664175590 ycmnankai@126.com

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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