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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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 criteria

Qualifiers

Age 18 - 70 years, female

Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive

Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease

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

Disqualifiers

Participated in other clinical trials within 4 weeks;

Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);

During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;

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;

Trial design

Treatments tested in this trial

  • Inetetamab and Paclitaxel ± Pertuzumab

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators