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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 (May 2026). This Phase 2/3 trial studies multiple treatments including HLX87 + HLX22 and HLX87 + Pertuzumab for her2 + breast cancer.

Phase 2/3RecruitingShanghai Henlius BiotechNCT07294508Data as of May 2026

Treatment: HLX87 + HLX22 · HLX87 + Pertuzumab · T-Dxd + Pertuzumab · THPThe 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

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Extracted eligibility criteria

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

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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