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

Launched by FUDAN UNIVERSITY · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with advanced breast cancer that tests positive for a protein called HER2. The researchers want to see how well the combination of a medication called Inetetamab and a chemotherapy drug called Paclitaxel, with or without another drug named Pertuzumab, works for these patients. They aim to gather information about the effectiveness and safety of this treatment, which could help doctors make better decisions for patients with similar conditions in the future.

To be eligible for the trial, participants need to be women aged between 18 and 70 who have been diagnosed with HER2-positive breast cancer that cannot be treated surgically. They should not have received certain types of treatment in the past year and must be in good enough health to participate. Those who take part will undergo regular check-ups to monitor their health and the effects of the treatment. The trial is not yet recruiting participants, but it aims to provide valuable insights into how this treatment combination can benefit women facing advanced breast cancer.

Gender

FEMALE

Eligibility criteria

• 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.