RecruitingPhase 2/3

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

China706 participantsStarted 2026-02-27

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).

What they're measuring

Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)

Timeframe: up to 26 months

Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)

Timeframe: up to 37 months

Trial details

NCT IDNCT07294508

SponsorShanghai Henlius Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-15

Contact for this trial

Maoqing Fu, Dr

021-33395800 Maoqing_fu@henlius.com

View on ClinicalTrials.gov More HER2 + Breast Cancer trials