HLX22 plus HLX87 as first-line treatment for HER2-positive recurrent or metastatic breast cancer

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

This will test whether combining HLX22 with HLX87 helps adults with HER2-positive recurrent or metastatic breast cancer when given as a first-line treatment.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 706 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Henlius Biotech (industry)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07294508 on ClinicalTrials.gov

What this trial studies

The program includes two open-label, randomized, parallel-controlled stages: a Phase II portion focused on objective response rate (ORR) and progression-free survival (PFS), followed by a Phase III portion with PFS as the primary endpoint. Patients with centrally confirmed HER2-positive recurrent or metastatic breast cancer who have not received prior chemotherapy or HER2-targeted therapy for advanced disease are eligible. Treatment arms include HLX22+HLX87 and comparator regimens such as HLX87+pertuzumab, T-DXd+pertuzumab, and THP, with central imaging review by RECIST v1.1. The trial is sponsored by Shanghai Henlius Biotech and conducted at the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing.

Who should consider this trial

Good fit: Adults (≥18) with centrally confirmed HER2-positive recurrent or metastatic breast cancer, measurable disease by RECIST v1.1, ECOG 0–1, adequate organ function, and no prior systemic chemotherapy or HER2-targeted therapy for advanced disease are the intended participants.

Not a fit: Patients who previously received HER2-targeted therapy or chemotherapy for advanced disease, those with poor performance status, significant comorbidities, or non-HER2-driven tumors are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could offer a more effective first-line option that prolongs tumor control and progression-free survival for patients with HER2-positive metastatic breast cancer.

How similar studies have performed: Combinations of dual HER2-targeted antibodies (for example pertuzumab plus trastuzumab with chemotherapy) and antibody–drug conjugates like T-DXd have shown substantial clinical benefit in HER2-positive metastatic breast cancer, and this trial applies that concept to new agents.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Fei Ma, Dr — Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
• Study coordinator: Maoqing Fu, Dr

Conditions: HER2 + Breast Cancer