HER2 + Breast Cancer
Conditions
Brief summary
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from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
Detailed description
Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).
Interventions
DRUGHLX22
15 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W
DRUGTrastuzumab
Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
DRUGCapecitabine
1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
DRUGPaclitaxel
175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
DRUGDocetaxel
75-100 mg/m2, D1, Q3W, IV
DRUGEribulin
1.4 mg/m2, D1 and D8, Q3W, IV
DRUGVinorelbine
25-30 mg/m2, D1 and D8, Q3W, IV
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) assessed by the blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to 2 years | 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 |
|---|---|---|
| Progression-free survival (PFS) assessed by the BICR as per RECIST 1.1 | up to 5 years | 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 assessed by the investigator as per RECIST 1.1 | up to 2 years | — |
| PFS assessed by the investigator as per RECIST 1.1 | up to 5 years | — |
| Duration of response (DoR) assessed by the BICR and the investigator as per RECIST 1.1 | up to 2 years | DoR is defined as the time from the date of first achievement of CR or PR (whichever is documented first) to the date of the first documentation of PD or death (whichever occurs first) |
| Overall survival (OS) | up to 5 years | OS is defined as the time from randomization to death due to any cause. |
| Adverse Events (AEs) | time from the date of the first dose of study drug until 90 days after last dose, assessed up to 5 years | Incidence and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0. |
Contacts
CONTACTMingxia Xu
Outcome results
None listed