A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.

Eligibility criteria

Qualifiers

Subjects voluntarily enrolled in this study with good compliance

Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1

HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology

Defined hormone receptor (HR) status

Disqualifiers

It is known that there is spinal cord compression or active central nervous system metastasis;

Subjects with only skin and/or brain lesions as target lesions

Combined diseases and medical history

Have had or currently have other malignant tumors within the past 5 years of randomization

Trial design

Treatments tested in this trial

  • TQB2102 for Injection
  • Docetaxel combined + Trastuzumab +Pertuzumab

Treatment groups

642 Participants
are divided into 2 treatment groups