A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLX22, Trastuzumab Deruxtecan.
- Who it may be relevant to
- Registry conditions: HER2-low Hormone Receptor Positive Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care
Overview
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Detailed description
experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).
Interventions
- Drug HLX22
HLX22 15mg/kg Q3W - Drug Trastuzumab Deruxtecan
Trastuzumab Deruxtecan 5.4mg/kg Q3W
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Up to 5 years]
- Objective response rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (3)
- PFS [Time frame: Up to 5 years]
- ORR [Time frame: Up to 2 years]
- Aderse events (AE) [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Male/female who are at least 18 years of age on the day of signing the informed consent.
- With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
- HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
- Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- ECOG PS: 0-1.
- Expected survival ≥ 6 months.
- Had adequate organ function
Exclusion criteria
- Patients with other malignant tumors within 3 years before the randomization
- Previous treatment with any HER2-target therapy
- Uncontrolled or significant cardiovascular disease or infection
- Lung-specific intercurrent clinically significant illnesses
- Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
- Patients with spinal cord compression or clinically active central nervous system metastases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06832202 · HLX22-BC201