OncoMatch/Clinical Trials/NCT07294508
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
Is NCT07294508 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including HLX87 + HLX22 and HLX87 + Pertuzumab for her2 + breast cancer.
Treatment: HLX87 + HLX22 · HLX87 + Pertuzumab · T-Dxd + Pertuzumab · THP — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and ISH+)
HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER2-targeted therapy
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer
Cannot have received: chemotherapy
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer
Cannot have received: antibody-drug conjugate
Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.
Cannot have received: anthracycline (doxorubicin)
Exception: Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent)
Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).
Lab requirements
Blood counts
Adequate organ functions
Kidney function
Adequate organ functions
Liver function
Adequate organ functions
Adequate organ functions
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07294508 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages