Clinical trial · Interventional
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
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 + Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Eribulin | Drug | Eribulin | ALIAS |
| HLX22 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- HLX22 + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)
- interventionNames
- Drug: HLX22
- Drug: Trastuzumab
- Drug: Capecitabine
- Drug: Paclitaxel
- Drug: Docetaxel
- Drug: Eribulin
- Drug: Vinorelbine
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)
- interventionNames
- Drug: Trastuzumab
- Drug: Capecitabine
- Drug: Paclitaxel
- Drug: Docetaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Uncontrolled or severe cardiovascular disease. * History of cerebrovascular accident within 6 months prior to randomization. * Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment. * Active infection. * Active tuberculosis. * Presence of spinal cord compression or clinically symptomatic central nervous system metastases. * Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization * Pregnant or lactating women or women who plan to become pregnant during the study period. * History of immunodeficiency or history of organ transplantation.
References
Publications (0)
Data not yet available