NCT07824869Not yet recruitingPhase 2
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
A Multicenter, Randomized, Double-Blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Shanghai Henlius Biotech
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07824869
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 31 Oct 2026 to the primary completion date, 31 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of any other malignancy within 2 years prior to signing the ICF.
- Prior use of doxorubicin with a cumulative in vivo dose of \> 360 mg/m2.
- Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.0.
- History of cerebrovascular accident within 6 months prior to randomization.
- Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization
Other illness
- Uncontrolled or severe cardiovascular disease.
- Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment.
- Active infection.
- Active tuberculosis.
- History of immunodeficiency or history of organ transplantation.
Other
- Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
- Pregnant or lactating women or women who plan to become pregnant during the study period.
Who the study is looking for
- Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
- Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
- HER2 positive confirmed by central laboratory.
- Hormone receptor (HR) status confirmed by local laboratory.
- Patients who have progressed after treatment containing within HER2 ADC
- Presence of at least one measurable lesion according to the RECIST v1.1.
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.