HER2-low Hormone Receptor Positive Breast Cancer
Conditions
Brief summary
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
DRUGHLX22
HLX22 15mg/kg Q3W
DRUGTrastuzumab Deruxtecan
Trastuzumab Deruxtecan 5.4mg/kg Q3W
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male/female who are at least 18 years of age on the day of signing the informed consent. 2. With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer. 3. 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 4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only. 5. ECOG PS: 0-1. 6. Expected survival ≥ 6 months. 7. Had adequate organ function
Exclusion criteria
1. Patients with other malignant tumors within 3 years before the randomization 2. Previous treatment with any HER2-target therapy 3. Uncontrolled or significant cardiovascular disease or infection 4. Lung-specific intercurrent clinically significant illnesses 5. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis 6. Patients with spinal cord compression or clinically active central nervous system metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 5 years | Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1 . PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. |
| Objective response rate (ORR) | Up to 2 years | Objective Response Rate (ORR) assessed by IRRC per RECIST v1.1. ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to 5 years | PFS assessed by investigator per RECIST 1.1 . PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. |
| ORR | Up to 2 years | ORR assessed by investigator per RECIST v1.1. ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 |
| Aderse events (AE) | Up to 5 years | AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. |
Countries
China
Contacts
Primary ContactYun Li
Outcome results
None listed