TQB2930 Injection for the Treatment of HER2-positive Advanced Breast 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

TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.

Eligibility criteria

Qualifiers

Subjects voluntarily participate in this study and sign the informed consent form;

Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy >3 months;

Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;

Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;

Disqualifiers

Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);

Uncontrolled toxicities (>CTCAE Grade 1) from prior therapies (excluding alopecia);

Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;

Non-healing wounds or fractures;

Trial design

Treatments tested in this trial

  • TQB2930+ chemotherapy
  • Trastuzumab+ chemotherapy

Treatment groups

416 Participants
are divided into 2 treatment groups