A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer

Eligibility criteria

Qualifiers

Advanced or metastatic breast cancer.

HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.

Positive or negative for hormone receptor HR (including estrogen receptor [ER] and progesterone receptor [PgR]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).

Disqualifiers

1. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).

Trial design

Treatments tested in this trial

  • HLX87 + HLX22
  • HLX87 + Pertuzumab
  • T-Dxd + Pertuzumab
  • THP

Treatment groups

706 Participants
are divided into 4 treatment groups

Sponsors and collaborators