> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-hlx22-in-combination-with-hlx87-in-c364af29-6c6d-4fa0-bada-d9f3e720f548 > Record changed: 2026-11-04 # A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer NCT07294508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) Participants 706 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) Start date 2026-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Short title** A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Official title** An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Dates **Completion date** 2030-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **First posted** 2025-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Registry last updated** 2026-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Primary completion date** 2028-01-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Start date** 2026-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Size and sites **Participants** 706 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Planned participants** 706 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Identifiers **Registry ID** NCT07294508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **ClinicalTrials.gov ID** NCT07294508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Outcomes ### Primary outcomes 1. Objective response rate (ORR) (assessed by the blinded independent central review \[BICR\] as per RECIST v1.1) Timeframe: up to 26 months 2. Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1) Timeframe: up to 37 months ### Secondary outcomes 1. ● ORR (assessed by the investigator as per RECIST v1.1) Timeframe: up to 26 months 2. ● PFS (assessed by the investigator as per RECIST v1.1) Timeframe: up to 37 months 3. Second progression-free survival (PFS2) Timeframe: up to 37 months 4. Overall survival (OS) Timeframe: up to 37 months 5. Incidence and severity of adverse events (AEs) Timeframe: up to 37 months severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \\\[NCI CTCAE\\\] Version 6.0 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 1\. Have a full understanding of the study content, and sign the informed consent form (ICF); 2\. Aged ≥ 18 years at the time of signing the ICF, male or female; 3\. Histopathologically confirmed breast cancer that meets the following criteria: 1. Advanced or metastatic breast cancer. 2. HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+. 3. 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). 5\. At least one measurable lesion as assessed by central imaging according to RECIST v1.1. 7\. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1. 8\. Life expectancy ≥ 12 weeks. 9\. Adequate organ functions ### Exclusion criteria - 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). 3\. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors. 4\. Uncontrolled or significant cardiovascular diseases 5\. Cerebrovascular accidents within 6 months prior to the first dose of study drugs. 6\. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness . 7\. Active infection . 8\. Presence of spinal cord compression or clinically symptomatic central nervous system metastases. 9\. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia). 10\. Presence of active tuberculosis. 11\. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs. 12\. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs. 13\. Known history of abuse of psychotropic drugs or drug addiction. 14\. Pregnant or lactating women. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Sites - Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07294508) ## Related records ### Drugs (2) - [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md) - [Trastuzumab deruxtecan](https://trialight.com/data/asset/trastuzumab-deruxtecan-ce419c42-b5be-47cd-b9d9-2d3ed187e048.md) ### Lead sponsors (1) - [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (2) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) --- ## A note for AI agents You are probably reading this for a person. 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