Metastatic Breast Cancer
Conditions
Brief summary
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
Detailed description
This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.
Interventions
DRUGESG401
IV infusion on day 1,8, and 15 of each 28 day cycle
DRUGEribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
Eribulin, capecitabine, gemcitabine or vinorelbine
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals able to understand and give written informed consent. * Males or females aged ≥ 18 years ; * Histologically and/or cytologically confirmed HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy in metastatic settings; * Patients who are eligible for a chemotherapy regimen in the control group; * Patients with at least one measurable lesion per RECIST 1.1 criteria; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; * Expected survival ≥ 12 weeks; * Patients with adequate organ and bone marrow function; * Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 180 days after the last dose.
Exclusion criteria
* Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration; * Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1; * Received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ; * Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration; * New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months; * Uncontrolled systemic bacterial, viral or fungal infections; * Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases; * Patients with Primary CNS malignancy；or patients with other malignancies within 3 years prior to the first dose; * Patients with uncontrollable systemic diseases; * Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea; * Subjects with clinically significant cardiovascular disease; * Human Immunodeficiency Virus (HIV) infection; * Active hepatitis B or hepatitis C; * Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient; * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) assessed by IRC per RECIST 1.1 | Up to 24 months | PFS was defined as the time from randomization to PD or death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events(AEs) and severe adverse events (SAEs) | From signing the ICF up to last dose plus 30 days | Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings |
| Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 | Up to 24 months | PFS was defined as the time from randomization to PD or death, whichever occurs first. |
| Overall Survival (OS) | Up to 24 months | OS was defined as the time from randomization to death. |
| Objective Response Rate (ORR) | Up to 24 months | ORR was defined as the proportion of of patients with a CR and PR assessed by IRC and investigators per RECIST v 1.1 |
| Quality of life evaluated using the NCC-BC-A scale | Up to 24 months | To assess the impact of ESG401 on disease related symptoms and quality of life of patients using the NCC-BC-A scale |
| Duration of Response (DoR) | Up to 24 months | From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first. |
| Clearance | Up to 24 months | Mean population clearance will be derived from pooled data of drug concentrations. Covariates of influence on drug clearance will be incorporated within a population pharmacokinetic model. |
| Volume of distribution | Up to 24 months | Mean population volume of distribution will be derived from pooled data of drug concentrations. Covariates of influence on volume of distribution will be incorporated within a population pharmacokinetic model. |
| ADA | Up to 24 months | Incidence of anti-drug antibodies |
| Clinical Benefit Rate (CBR) | Up to 24 months | CBR was defined as the proportion of patients with a CR or PR or with SD at Week 24 assessed by IRC and investigators per RECIST v 1.1 |
Countries
China
Contacts
Primary ContactYong Yuan, Master Degree
Outcome results
None listed